[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-cell-non-hodgkin-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-cell-non-hodgkin-lymphoma":644},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,38,0,25,[9,46,70,97,118,137,164,198,235,259,280,301,329,358,384,411,433,463,482,502,529,547,566,594,615],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100602434",false,"NCT07123454","A Phase I\u002FII Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma","A Modular Phase I\u002FII Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Efficacy of AZD4512 Monotherapy or in Combination With Other Anticancer Agent(s), in Participants With Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma (B-NHL) (Lumi-NHL)","Lumi-NHL","Key Inclusion Criteria:\n\n* Eligible patients must be adults (≥18 years)\n* Documented histologically confirmed diagnosis of B-cell non-Hodgkin lymphoma (B-NHL) as per World Health Organization (WHO) 2022 classification. In the dose escalation phase, any B-NHL subtype is allowed (excluding some subtypes), while the backfill phase restricts inclusion to defined subtypes: large B-cell lymphomas (as defined as Diffuse large B-cell lymphoma (DLBCL), Grade 3b Follicular lymphoma (FL), high-grade B-cell lymphoma (HGBCL) NOS, DLBCL\u002FHGBCL with MYC and BCL2 rearrangements, primary mediastinal Large B-cell lymphoma, T-cell\u002Fhistiocyte-rich LBCL, and transformed indolent lymphoma) and mantle cell lymphoma.\n* Patients must have relapsed or refractory disease after at least two prior lines of systemic therapy and lack additional standard options with established benefit:\n\nA)LBCL patients must have progressed after both anti-CD20 and at least one systemic chemotherapy regimen, and have considered-or be ineligible for-CAR-T, T cell engager, and stem cell transplant modalities.\n\nB) Mantle cell lymphoma (MCL) patients must have had anti-CD20 and Bruton's Tyrosine Kinase (BTK) inhibitor.\n\nAdditional criteria include measurable disease by Lugano 2014, Eastern Cooperative Oncology Group (ECOG) performance status ≤2, and adequate organ and bone marrow function (as specified by blood counts, cardiac ejection fraction, renal and hepatic parameters, and coagulation indices).\n\nKey Exclusion criteria\n\n* Patients are excluded if they have a diagnosis of post-transplant lymphoproliferative disease, Richter's transformation, Burkitt's lymphoma, or chronic lymphocytic leukemia (CLL)\u002F Small lymphocytic lymphoma (SLL), Waldenstrom Macroglobulinemia\u002F Lymphoplasmacytic Lymphoma, or if they have active Central nervous system (CNS) involvement from their B-NHL. Exclusion also applies to those who have received Chimeric antigen receptor-T (CAR-T) or T cell engager therapies within 90 days prior to Cycle 1 Day 1 (C1D1), any investigational drug or other systemic anticancer therapies (except low-dose corticosteroids) within 21 days or 5 half-lives, and curative radiation within 14 days (localized palliative radiotherapy is allowed).\n* Other exclusions include allogeneic Hematopoietic stem cell transplantation (HSCT) within 180 days (unless stable without active (graft-versus-host disease) GVHD for ≥2 months), autologous HSCT within 90 days (unless resolved toxicities), major surgery within 28 days, use of strong CYP3A inhibitors within 14 days or 5 half-lives before the dosing date, use of QTc-prolonging agents within 5 half-lives before the dosing date, or other malignancies within two years. Patients with unresolved ≥ Grade 2 AEs from prior therapy (except specified tolerable conditions), serious uncontrolled medical conditions, active infection within 14 days, or history\u002Fsuspicion of significant interstitial lung disease\u002Fpneumonitis are also excluded.\n* Females who are pregnant or breastfeeding are not eligible.","ALL","18 Years",{"count":20,"type":21},91,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a Phase I\u002FII open-label, global multicenter study to evaluate the safety and efficacy of AZD4512 monotherapy or in combination with other anticancer agent(s), in participants with Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma (B-NHL).",[28],"B-cell Non-Hodgkin Lymphoma",[30,31,32],"AZD4512","Non-Hodgkin Lymphoma (NHL)","Relapsed\u002FRefractory","RECRUITING","2026-06-26",{"date":36,"type":37},"2026-06-29","ACTUAL",{"date":39,"type":37},"2025-09-24",{"date":41,"type":21},"2028-03-01",{"name":43,"class":44},"AstraZeneca","INDUSTRY",22,{"id":47,"slug":4,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100609902","NCT07220616","A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies","A Phase 1\u002F2, Multicenter, Open-Label, Multi-Cohort, First-in Human Trial of DS3790a, a DXd-ADC Targeting CD37, for Hematological Malignancies","To be eligible to participate in this trial, an individual must meet all the following criteria:\n\n1. Sign and date the ICF, prior to the start of any trial-specific procedures.\n2. Adults \\>=18 years at the time the ICF is signed.\n3. History of one of the histologically documented hematologic malignancies according to the 5th edition of WHO classification as specified in the protocol.\n4. NHL participants only: Agree to provide baseline tumor tissue samples as specified in the protocol.\n5. ECOG PS of 0, 1 or 2 assessed no more than 14 days prior to initiation of trial intervention.\n6. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of trial intervention as specified in the protocol.\n7. Has an LVEF \\>=50% by either an ECHO or MUGA within 28 days before the trial starts.\n8. Life expectancy of at least 3 months.\n9. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other trial procedures, and trial restrictions.\n10. A woman of childbearing potential is eligible to participate if she meets all criteria as specified in the protocol.\n11. A male participant capable of producing sperm is eligible to participate if he agrees to all criteria as specified in the protocol.\n\nAn individual who meets any of the following criteria will be excluded from participating in this trial:\n\n1. Prior Allo-SCT.\n2. Prior solid organ transplantation.\n3. Inadequate washout period before initiation of trial intervention as specified in the protocol.\n4. Evidence of brain or leptomeningeal disease (spinal cord or CNS metastases) based on history and physical examination, unless treated and with radiologically documented lack of progression within 4 weeks prior to initiation of trial intervention.\n5. Uncontrolled or significant cardiovascular disease as specified in the protocol.\n6. Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.\n7. Has a history of (noninfectious) ILD\u002Fpneumonitis that required corticosteroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n8. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder and any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement, or prior pneumonectomy.\n9. Has been diagnosed with another malignancy within the previous 3 years.\n10. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and lymphocytopenia) not yet resolved to NCI-CTCAE Version 5.0, Grade \\\u003C=1 or baseline.\n11. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.\n12. Has active or uncontrolled HBV, HCV, or HIV infections.",{"count":53,"type":21},420,[24,25],"This clinical trial is designed to assess the safety, preliminary efficacy, and pharmacokinetics (PK) of DS3790a monotherapy and combination regimens in participants with hematological malignancies.",[57,28],"Hematological Malignancies",[57,59,60],"DS3790a","B-cell non-Hodgkin lymphoma","2026-06-23",{"date":34,"type":37},{"date":64,"type":37},"2026-01-16",{"date":66,"type":21},"2030-11-30",{"name":68,"class":44},"Daiichi Sankyo",5,{"id":71,"slug":4,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100556568","NCT06526793","Surovatamig (AZD0486) as Monotherapy in Participants With Relapsed\u002FRefractory (R\u002FR) B-cell NHL","A Modular Phase 2, Single-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Surovatamig (AZD0486) in Participants With Relapsed or Refractory (R\u002FR) B-cell Non-Hodgkin Lymphoma (SOUNDTRACK-B)","SOUNDTRACK-B","1. Key Inclusion Criteria:\n\n   * Aged 18 years old and above\n   * Histologically confirmed relapsed refractory FL (Module 1) and LBCL (Module 2) after at least 2 prior lines of therapy\n   * ECOG performance status 0 to 2\n   * Locally confirmed CD-19 expression in lymphoma cells after progression from last CD 19 directed therapy\n   * FDG-avid disease with at least one bi-dimensionally measurable nodal lesion (defined as \\> 1.5 cm in its longest dimension), or extranodal lesion (defined as \\> 1.0 cm in its longest dimension)\n   * Adequate hematological function: ANC ≥ 1000\u002Fmm3, platelets\n\n     * 75,000\u002Fmm3, hemoglobin ≥ 9 g\u002FdL. Transfusion and\u002For growth factor are allowed but counts must be stable for at least 72 hours afterwards prior to screening\n   * Adequate liver function: total bilirubin \\\u003C1.5x ULN, AST\u002FALT ≤ 3xULN or \\\u003C 5 × ULN in the presence of lymphoma involvement of the liver\n   * Adequate renal function: creatinine clearance (CrCl) of ≥ 45 mL\u002Fmin\n   * Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram or MUGA\n\n   The above is a summary, other inclusion criteria details may apply.\n2. Key Exclusion Criteria:\n\n   * Diagnosis of CLL, Burkitt lymphoma, or Richter's transformation\n   * Active CNS involvement by B-NHL\n   * Leukemic presentation of B-NHL\n   * History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic, or that the treating investigator considers to have the potential to interfere with the evaluation of safety, such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, neurodegenerative disorder including Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or other severe mental illness.\n   * Prior therapy with T-cell engager (TCE) within 8 weeks, autologous Hematopoietic Stem Cell Transplantation (HSCT) within 12 weeks, CAR T- cell therapy within 6 months, or prior allogeneic HSCT within 24 weeks of first dose of surovatamig\n   * Requires chronic immunosuppressive therapy\n   * Unresolved non hematological AEs ≥ Grade 2 from prior therapies; history of ≥ Grade 3 CRS or neurotoxicity from prior CAR-T or TCE therapy\n   * History of major cardiac abnormalities.\n   * If female, participant must not be pregnant or breastfeeding.\n\nThe above is a summary, other exclusion criteria details may apply.",{"count":78,"type":21},270,[25],"This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of surovatamig (AZD0486) monotherapy in adult participants with relapsed\u002Frefractory B-cell non-Hodgkin lymphoma (NHL) who have received at least two prior lines of therapies. The study has 2 Modules: Module 1 for FL and Module 2 for LBCL.",[28,82,83],"Follicular Lymphoma (FL)","Large B-Cell Lymphoma (LBCL)",[85,86,82,83,87,32],"AZD0486","Surovatamig","Non-Hodgkin lymphoma (NHL)","2026-06-22",{"date":90,"type":37},"2026-06-25",{"date":92,"type":37},"2024-11-27",{"date":94,"type":21},"2032-10-21",{"name":43,"class":44},94,{"id":98,"slug":4,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100641930","NCT07658352","A First-in-Human Study of HP-002 for Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma","An Open-label, First-in-human Dose Escalation and Dose Expansion Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HP-002 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.\n* Patients with relapsed or refractory B-cell non-Hodgkin lymphoma subtypes (CLL\u002FSLL, MCL, MZL, DLBCL, FL, WM, and PCNSL).\n\nExclusion Criteria:\n\n* Prior use of a BTK protein degrader.",{"count":104,"type":21},114,[24,25],"This is an open-label, first-in-human dose escalation and dose expansion Phase I\u002FII clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HP-002 in patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma This study consists of two phases: a dose-exploration phase and a dose-expansion phase.\n\nThe safety and tolerability of HP-002 will be evaluated in Phase 1 study, as well as the maximum tolerated dose (MTD) and the recommended dose level for Phase 2 study will be determined.\n\nThe efficacy of HP-002 will be evaluated in Phase 2 study.",[108],"B-Cell Non-Hodgkin Lymphoma","NOT_YET_RECRUITING","2026-06-16",{"date":88,"type":37},{"date":34,"type":21},{"date":114,"type":21},"2031-06-26",{"name":116,"class":44},"Shanghai Helioson Pharmaceutical Co., Ltd.",1,{"id":119,"slug":4,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":129,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100642056","NCT07661537","A Clinical Study of SHR-3079 in B-cell Non-Hodgkin Lymphoma","An Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-3079 Injection in Participants With B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Aged ≥ 18 years old;\n2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, expected survival ≥ 3 months;\n3. Histologically confirmed B-NHL;\n4. Participant population: Have received ≥ 1 line of standard anti-tumor treatment, and have not achieved response after the latest treatment or have progressive disease after the treatment;\n5. Have measurable lesions;\n6. Have adequate organ function;\n7. Male participants and female participants of childbearing potential must use adequate and effective contraceptive measures during the study and within 3 months after the last drug administration of SHR-3079. Female participants must not be lactating and must have a negative blood HCG test result within 7 days before the first dose;\n8. Voluntarily sign the ICF, have good compliance, and be willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Central nervous system (CNS) infiltration;\n2. Prior chemotherapy or other anti-lymphoma agents administered within 4 weeks before the first dose of study treatment;\n3. Major surgery within 4 weeks before signing the ICF, or plan to undergo major surgery during the study period;\n4. Receipt of CAR-T therapy or autologous stem cell transplant within 12 weeks prior to enrollment;\n5. Receipt of allogeneic hematopoietic stem cell transplantation;\n6. Prior solid organ transplantation;\n7. Positive hepatitis C virus (HCV) antibody with HCV-RNA copy number above the upper limit of normal of the study site; positive hepatitis B surface antigen \\[HBsAg\\] and\u002For positive hepatitis B core antibody (HBcAb) with HBV DNA copy number above the upper limit of normal of the study site;\n8. Presence of severe disorders involving major organ systems;\n9. Pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention;\n10. Pregnant, lactating women, or women planning to become pregnant;\n11. Have other serious physical or mental illness, laboratory test abnormalities, or other factors that may increase the risk of study participation or interfere with the study results.",{"count":125,"type":21},90,[24],"The study is being conducted to evaluate the safety and tolerability of SHR-3079, and to explore the Dose-limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of SHR-3079 in patients with B-cell non-Hodgkin lymphoma.",[28],{"date":88,"type":37},{"date":131,"type":21},"2026-06",{"date":133,"type":21},"2028-12",{"name":135,"class":44},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.",2,{"id":138,"slug":4,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":117},"100618723","NCT07335328","Fully Human Bispecific Anti-CD20, Anti-CD19 CAR T Cells for Patients With Relapsed and\u002For Refractory B Cell Malignancies","Phase 1 Study of a Fully Human Bispecific Anti-CD20, Anti-CD19 CAR T Cells for Patients With Relapsed and\u002For Refractory B Cell Malignancies","General Inclusion Criteria for All Patients\n\n1. Patients must be aged ≥ 18 years and ≤80 years with relapsed or refractory B-cell malignancy.\n2. Absolute CD3 count ≥50 mm\\^3.\n3. Magnetic resonance imaging (MRI) brain and lumbar puncture with cerebral spinal fluid (CSF) analysis by cytology and flow cytometry without evidence of central nervous system (CNS) involvement ONLY in patients with:\n\n   1. A history of CNS involvement OR\n   2. A clinical suspicion at the time of enrollment.\n4. Karnofsky performance score ≥70.\n5. Adequate hepatic function, defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \\\u003C3 × upper limit of normal (ULN); serum bilirubin \\\u003C2.0 mg\u002FdL, or considered not clinically significant as per the clinical principal investigator's discretion (e.g., Gilbert's or indirect hyperbilirubinemia).\n6. Absolute Neutrophil Count (ANC) ≥1000 with no Granulocyte Colony-Stimulating Factor (G-CSF) within 72 hours or pegylated G-CSF within 14 days.\n7. Platelets ≥50,000 with no transfusion within 72 hours.\n8. Adequate renal function, defined as creatinine clearance ≥50 mL\u002Fmin measured by CKD-EPI 2021 calculator OR 24-hour urine collection.\n9. Left ventricular ejection fraction of ≥45% -- by cardiac echocardiogram (ECHO) or Multigated Acquisition scan (MUGA) -- and adequate pulmonary function as indicated by room air oxygen saturation of ≥92%.\n10. Expected survival \\>12 weeks.\n11. No contraindication to central line access.\n12. Patient has demonstrated compliance with prior therapies.\n13. Meet criteria for regarding fertility and contraception detailed below.\n14. Negative urine or serum pregnancy test in females of childbearing potential at study entry.\n15. Agree to practice birth control during the study.\n16. Able to provide written informed consent.\n\nDisease-Specific Inclusion Criteria\n\n1. Patients must meet at least one of the following criteria within the categories below:\n\n   a. CAR\u002FBispecific antibody exposed:\n\n   i. Relapsed after prior murine CD19 autologous CAR-T cell therapy and be \\>90 days post prior CAR-T cell therapy OR relapsed after bispecific T-cell engaging therapy as a second or later line treatment.\n\n   ii. \\\u003C5% presence of circulating CAR-T cells as measured by flow cytometry in patients with prior CD19 CAR T cell exposure.\n\n   b. CAR naïve patients\n\n   i. For Diffuse Large B-Cell Lymphoma (DLBCL): Progressed after two or more lines of therapy, including at a minimum CD20 antibody and combination cytotoxic chemotherapy regimen (e.g., CHOP, CHP, EPOCH, HyperCVAD) or relapse\u002Fprogression after autologous stem cell transplant\n\n   ii. For Chronic Lymphocytic Leukemia (CLL): Progressed after two or more lines of therapy, including both a covalent Bruton tyrosine kinase (BTK) inhibitor and a BCL2 inhibitor\n\n   iii. For Mantle Cell Lymphoma (MCL): Progressed after two lines of therapy, including CD20 antibody, BTK inhibitor, and one cytotoxic chemotherapy regimen (e.g., bendamustine, cytarabine, CHOP)\n2. Patients must have measurable disease defined as:\n\n   1. For B-cell NHL (DLBCL and MCL): Measurable disease must be documented within 4 weeks of the time of consent, defined as nodal lesions greater than 15 mm in the long axis or extranodal lesions \\>10 mm in long and short axis OR bone marrow involvement that is biopsy-proven for B-cell Non-Hodgkin Lymphoma (NHL)\n   2. For CLL\u002F Small Lymphocytic Lymphoma (SLL): Indication for treatment as defined as any of the following: measurable lymph nodes ≥ 1.5 cm in the greatest transverse diameter and\u002For hepatomegaly or splenomegaly OR bone marrow involvement with ≥10% CLL involvement\n\nExclusion Criteria for All Patients\n\n1. Positive beta human chorionic gonadotropin (hCG) test in female of child-bearing potential.\n2. Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.\n3. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \\>20 mg of prednisone or equivalent daily.\n4. Presence of Grade ≥3 non-hematologic toxicities per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)version 5.0 unless believed to be due to underlying disease.\n5. Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. A minimum of 14 days or 5 half-lives of the drug, whichever is shorter, of washout is required prior to apheresis.\n6. Patients with active CNS involvement by malignancy on MRI or by lumbar puncture:\n\n   a. Patients with prior CNS disease that have been effectively treated will be eligible, provided treatment was \\>4 weeks before enrollment and a remission documented within 8 weeks of planned CAR-T cell infusion by MRI brain and CSF analysis.\n7. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are \\\u003C100 days post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.\n8. Anti-CD20 antibody treatment within 4 weeks of cell infusion.\n9. Anti-CD19 antibody treatment within 4 weeks of cell infusion.\n10. Cytotoxic chemotherapy other than lymphodepletion within 14 days of the lymphodepletion start date.\n11. Cytotoxic chemotherapy treatment within 14 days or steroid treatment (other than replacement dose steroids) within 7 days prior to apheresis collection for CAR T cells.\n12. Oral chemotherapeutic agents or antibody-directed treatment within 7 days of apheresis:\n\n    a. BTK inhibitors are allowed until 1 day prior to apheresis and can be restarted until 1 day prior to lymphodepletion.\n13. Patients post solid organ transplant who develop high-grade lymphomas or leukemias.\n14. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin (underlying low-grade lymphoma chronic lymphocytic leukemia\u002FFL\u002FMZL is allowable in patients with transformed large cell lymphoma).\n15. Refusal to participate in the long-term follow-up protocol.\n\nSpecial Criteria Regarding Fertility and Contraception Female subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure \\[hysterectomy or bilateral oophorectomy\\]) must have a negative serum or urine pregnancy test performed as part of the eligibility criteria.\n\nDue to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use a reliable and double-barrier methods of contraception during the follow-up period of the protocol.\n\nAcceptable birth control includes a combination of two of the following methods:\n\n* Condoms (male or female) with or without a spermicidal agent.\n* Diaphragm or cervical cap with spermicide.\n* Intrauterine device (IUD).\n* Hormonal-based contraception. Subjects who are not of reproductive potential (women who are premenarche or have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy, tubal ligation, salpingectomy, and\u002For bilateral oophorectomy, or men who have documented azoospermia) are eligible without requiring the use of contraception.","80 Years",{"count":145,"type":21},24,[24],"This is a Phase 1 interventional, single-arm, open- label, treatment study designed to evaluate the safety of h20.19 CAR T cells in patients with B-cell malignancies that have failed prior therapies.",[149],"B-cell Non Hodgkin Lymphoma",[151,152,153],"CAR-T","Chimeric antigen receptor T-cell therapy","CAR Therapy","2026-06-09",{"date":156,"type":37},"2026-06-11",{"date":158,"type":21},"2026-09-01",{"date":160,"type":21},"2031-05-01",{"name":162,"class":163},"Medical College of Wisconsin","OTHER",{"id":165,"slug":4,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":180,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},"100559431","NCT06564038","A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies","A Phase I\u002FII Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination With Other Anticancer Agents in Participants With Mature B-Cell Malignancies","Soundtrack-E","Inclusion Criteria:\n\nMaster Inclusion Criteria applicable to all substudies:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Contraception use during treatment and at least 90 days after final dose.\n* Confirmed CD19 expression if prior anti-CD19 therapy.\n\nSubstudy 1 Specific Inclusion Criteria:\n\n* Participants with CLL must require treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.\n* SLL: at least 1 measurable site per Lugano.\n* Absolute lymphocyte count (ALC) \\\u003C25000 cells\u002FmcL.\n* Cohort 1A and 1C: at least 2 prior lines of systemic therapy for CLL\u002FSLL.\n* Cohort 1B: at least 1 prior line of therapy and is bruton tyrosine kinase inhibitor (BTKi)-sensitive.\n\nSubstudy 2 Specific Inclusion Criteria:\n\n* MCL diagnosis per WHO.\n* Clinical Stage II, III, or IV by Ann Arbor Classification.\n* At least 1 measurable site per Lugano.\n* ALC \\\u003C 25000 cells\u002FmcL.\n* Cohort 2A and 2C: Relapse or progressed after 2 or more lines of therapy including BTKi.\n\nSubstudy 3 Specific Inclusion Criteria:\n\n* At least 1 measurable site as per Lugano.\n* Left ventricular ejection fraction (LVEF) ≥50%.\n* Participant must be no older than 79 years of age at the time of signing ICF.\n* Contraception at least 90 days after last dose of surovatamig or 4 months after last dose of vincristine, and 6 months after the last dose of cyclophosphamide, or doxorubicin.\n* Cohort 3A:\n\n  1. Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.\n  2. R\u002FR B-NHL after at least 1 prior lines of systemic therapy.\n  3. International Prognostic Index (IPI) 2-5.\n* Cohort 3B:\n\n  1. Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.\n  2. IPI score of 2 to 5.\n\nExclusion Criteria:\n\nMaster Exclusion Criteria applicable to all substudies:\n\n* Central nervous system (CNS) lymphoma.\n* Surgery within 14 days of study drug.\n* Clinically significant cardiovascular (CV) disease.\n* Unresolved Grade \\>2 AEs from prior anticancer therapy (except alopecia or fatigue).\n* Any systemic therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment.\n* Radiation therapy within 28 days.\n* Prior CAR T-cell therapy or autologous-haematopoietic stem cell transplant (HSCT) within 12 weeks or prior T-cell engager (TCE) within 8 weeks.\n* Prior Grade \\> 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) event.\n* Prior allogeneic HSCT or solid organ transplantation within 24 weeks of starting Cycle 1 Day 1.\n* Active, significant, uncontrolled infection or autoimmune disease requiring systemic therapy including participants with known history of haemophagocytic lymphohistiocytosis (HLH).\n\nSubstudy 1 Specific Exclusion Criteria:\n\n* CLL\u002FSLL transformation to more aggressive form of lymphoma.\n* Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist.\n\nSubstudy 3 Specific Exclusion Criteria:\n\n* Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusion large B-cell lymphoma (LBCL).\n* Cumulative dose of anthracycline \\>150 mg\u002Fm2.",{"count":172,"type":21},408,[24,25],"The purpose of this study is to assess the safety and efficacy of surovatamig (formerly AZD0486) administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies",[176,177,178,179,28],"Chronic Lymphocytic Leukaemia","Small Lymphocytic Lymphoma","Mantle-cell Lymphoma","Large B-cell Lymphoma",[181,182,183,184,185,186,187,188,189,86],"IgG4 fully human CD19xCD3 bispecific T-cell engager","B cell lymphoma","Subcutaneous","Acalabrutinib","Prednisone","Rituximab","Cyclophosphamide","Vincristine","Doxorubicin",{"date":191,"type":37},"2026-06-10",{"date":193,"type":37},"2025-01-30",{"date":195,"type":21},"2029-06-11",{"name":43,"class":44},64,{"id":199,"slug":4,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":22,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":136},"100287143","NCT03017820","A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma","MC1684 Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia, Lymphomas, or Histiocytic\u002FDendritic Cell Neoplasms","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Relapsed or refractory disease as follows:\n\n  * Groups A, B, C or D: Multiple myeloma (MM) previously treated with an immunomodulatory imide drug (IMID), a proteosome inhibitor, and an alkylating agent\n  * All Groups except D: Relapsed peripheral T-cell lymphoma (PTCL) of the following histologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell (ALCL), and mycosis fungoides (MF). Patients should have failed standard therapy and in the case of PTCL-NOS, AITL, and ALCL either have failed or be ineligible for high-dose therapy with autologous stem cell transplant\n  * Group B and C only: B-cell lymphoma (other than Burkitt's lymphoma), or histiocytic\u002Fdendritic cell neoplasms (HCN) at any stage\n  * Group E only: Relapsed peripheral T-cell lymphoma (PTCL) of the following histologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); anaplastic large cell (ALCL), and mycosis fungoides (MF)\n  * Group F only: Expansion Cohort for B-cell lymphoma (other than Burkitt's lymphoma) with low tumor burden\n  * Group G only: Expansion Cohort for peripheral T cell lymphoma (PTCL) with low tumor burden\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 2 times upper limit of normal (ULN) (obtained =\\\u003C 15 days prior to registration)\n* Creatinine =\\\u003C 2.0 mg\u002FdL (obtained =\\\u003C 15 days prior to registration)\n* Direct bilirubin =\\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* International normalized ratio (INR)\u002Fprothrombin time (PT) and activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* If baseline liver disease, Child Pugh score not exceeding class A (obtained =\\\u003C 15 days prior to registration)\n* Negative pregnancy test for persons of child-bearing potential (obtained =\\\u003C 15 days prior to registration)\n* FOR MULTIPLE MYELOMA ONLY: Measurable disease of multiple myeloma as defined by at least ONE of the following:\n\n  * Serum monoclonal protein \\>= 1.0 g\u002FdL by protein electrophoresis\n  * \\>= 200 mg of monoclonal protein in the urine on 24-hour electrophoresis\n  * Serum immunoglobulin free light chain \\>= 10 mg\u002FdL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\n* FOR MULTIPLE MYELOMA ONLY: Absolute neutrophil count (ANC) \\>= 1000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR MULTIPLE MYELOMA ONLY: Platelet (PLT) \\>= 100,000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR MULTIPLE MYELOMA ONLY: Hemoglobin \\>= 8.5 g\u002Fdl (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: No ANC restriction (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: PLT \\>= 10,000\u002FuL (transfusion to get platelets \\>= 10,000 is allowed) (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: Hemoglobin \\>= 7.5 g\u002Fdl (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: Absence of uncompensated disseminated intravascular coagulation (DIC- as diagnosed by standard International Society on Thrombosis and Hemostasis \\[ISTH\\] criteria)\n* FOR TCL\u002FBCL ONLY: ANC \\>= 1,000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: PLT \\>= 100,000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: Hemoglobin \\>= 8.5 g\u002Fdl (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: Measurable disease by CT or magnetic resonance imaging (MRI): must have at least one lesion that has a single diameter of \\> 2 cm or tumor cells in the blood \\> 5 x 10\\^9\u002FL; NOTE: skin lesions can be used if the area is \\> 2 cm in at least one diameter and photographed with a ruler and the images are available in the medical record\n* FOR HCN ONLY: ANC \\>= 1,000\u002FuL obtained =\\\u003C 15 days prior to registration\n* FOR HCN ONLY: PLT \\>= 100,000\u002FuL obtained =\\\u003C 15 days prior to registration\n* FOR HCN ONLY: Hemoglobin \\>= 8.0 g\u002Fdl obtained =\\\u003C 15 days prior to registration\n* FOR HCN ONLY: Measurable disease by CT or MRI: Must have at least one lesion that has a single diameter of \\>= 1.5 cm or tumor cells in the blood \\>5 x10\\^9\u002FL. NOTE: Skin lesions can be used if the area is \\>= 1.5 cm in at least one diameter and photographed with a ruler and the images are available in the medical record\n* Absence of active central nervous system (CNS) involvement; NOTE: pre-enrollment lumbar puncture not mandatory\n* Ability to provide written informed consent\n* Willingness to return to Mayo Clinic for follow-up\n* Life expectancy \\>= 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* Willing to provide mandatory biological specimens for research purposes\n\nExclusion Criteria:\n\n* Availability of and patient acceptance of curative therapy\n* Uncontrolled infection\n* Active tuberculosis or hepatitis, or chronic hepatitis\n* Any of the following prior therapies:\n\n  * Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) =\\\u003C 2 weeks prior to registration\n  * Immunotherapy (monoclonal antibodies) =\\\u003C 4 weeks prior to registration\n  * Experimental agent in case of AML or TCL within 4 half-lives of the last dose of the agent\n* New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia \\[SVT\\])\n* Active CNS disorder or seizure disorder or known CNS disease or neurologic symptomatology; in case of AML active CNS involvement as detected by lumbar puncture or neuro-imaging (only to be done if clinically indicated)\n* Human immunodeficiency virus (HIV) positive test result or other immunodeficiency or immunosuppression\n* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-Food and Drug Administration \\[FDA\\] approved indication and in the context of a research investigation);\n\n  * NOTE: in AML, the concurrent use of hydroxyurea to help control proliferative counts is allowed throughout the treatment protocol;\n  * NOTE: in TCL, patients may use topical emollients or corticosteroids, acetic acid soaks, etc. to control pruritus and prevent infection; no topical chemotherapy is allowed (no topical nitrogen mustard)\n* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:\n\n  * Pregnant women or women of reproductive ability who are unwilling to use effective contraception\n  * Nursing women\n  * Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment\n* AML ONLY: Current disseminated intravascular coagulopathy (DIC)\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP A (LOW TUMOR BURDEN) ONLY:\n\n  * Diagnosis of AML\n  * Multiple myeloma only: \\> 25% plasma cells or plasmacytoma \\> 5cm in largest diameter\n  * Lymphoma or HCN only: Any mass \\>5cm\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP B (HIGH TUMOR BURDEN) ONLY:\n\n  * Diagnosis of AML\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP C (COMBINATION WITH CYCLOPHOSPHAMIDE) ONLY:\n\n  * Diagnosis of AML\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP E (COMBINATION WITH CEMIPLIMAB) ONLY:\n\n  * Diagnosis of AML\n  * Diagnosis of AITL\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP F (BCL EXPANSION COHORT) ONLY:\n\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP G (PTCL EXPANSION COHORT) ONLY:\n\n  * Diagnosis of cutaneous TCL",{"count":205,"type":21},99,[24],"This phase I trial studies the best dose and side effects of the VSV-hIFNβ-NIS vaccine with or without cyclophosphamide and combinations of ipilimumab, nivolumab, and cemiplimab in treating patients with multiple myeloma, acute myeloid leukemia or lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). VSV-IFNβ-NIS is a modified version of the vesicular stomatitis virus (also called VSV). This virus can cause infection and when it does it typically infects pigs, cattle, or horses but not humans. The VSV used in this study has been altered by having two extra genes (pieces of DNA) added. The first gene makes a protein called NIS that is inserted into the VSV. NIS is normally found in the thyroid gland (a small gland in the neck) and helps the body concentrate iodine. Having this additional gene will make it possible to track where the virus goes in the body (which organs). The second addition is a gene for human interferon beta (β) or hIFNβ. Interferon is a natural anti-viral protein, intended to protect normal healthy cells from becoming infected with the virus. VSV is very sensitive to the effect of interferon. Many tumor cells have lost the capacity to either produce or respond to interferon. Thus, interferon production by tumor cells infected with VSV-IFNβ-NIS will protect normal cells but not the tumor cells. The VSV with these two extra pieces is referred to as VSV-IFNβ-NIS. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Immunotherapy with monoclonal antibodies, such as ipilimumab, nivolumab, and cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving VSV-IFNβ-NIS with or without cyclophosphamide and combinations of ipilimumab, nivolumab, and cemiplimab may be safe and effective in treating patients with recurrent peripheral T-cell lymphoma.",[108,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226],"Histiocytic and Dendritic Cell Neoplasm","Myelodysplastic Syndrome","Previously Treated Myelodysplastic Syndrome","Recurrent Adult Acute Myeloid Leukemia","Recurrent Anaplastic Large Cell Lymphoma","Recurrent Angioimmunoblastic T-Cell Lymphoma","Recurrent Mycosis Fungoides","Recurrent Plasma Cell Myeloma","Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma","Recurrent T-Cell Non-Hodgkin Lymphoma","Refractory Acute Myeloid Leukemia","Refractory Anaplastic Large Cell Lymphoma","Refractory Angioimmunoblastic T-Cell Lymphoma","Refractory Mycosis Fungoides","Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified","Refractory Plasma Cell Myeloma","Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma","Refractory T-Cell Non-Hodgkin Lymphoma","2026-06-08",{"date":191,"type":37},{"date":230,"type":37},"2017-04-04",{"date":232,"type":21},"2032-04-01",{"name":234,"class":163},"Mayo Clinic",{"id":236,"slug":4,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":244,"conditions":245,"keywords":248,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":258},"100437025","NCT04970901","A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)","A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)","Inclusion Criteria:\n\n* Male or female participant aged 18 years or older\n* Pathologic diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) B-NHL (2016 World Health Organization classification) who have failed, or been intolerant to any approved therapy and had received at least two systemic treatment regimens in Part 1; and at least one systemic treatment regimen in Part 2\n\n  * LBCL:\n\nPart 2 Arm E enrollment focused on LBCL only\n\n* DLBCL, not otherwise specified (NOS)\n* Germinal Center B-cell type\n* Activated B-cell type\n* Transformed FL (note: patients with transformed FL must have received at least one line of systemic therapy post-transformation to be eligible)\n* HGBCL, with MYC and BCL2 and\u002For BCL6 rearrangements\n* HGBCL, NOS\n* FL Grade 3b\n\n  * Arm F and Part 1 Arm E:\n* All LBCL histologies listed above\n* FL (Grade 1-3a)\n* MZL\n\n  * For Arm C only:\n* All histologies listed above\n* DLBCL (including transformed diseases)\n* MCL\n* BL\n\n  * Life expectancy of at least 24 weeks according to Investigator's judgement\n  * Need of systemic treatment for any of the listed indications as assessed by the investigator, including indolent B-NHLs (e.g. FL and MZL)\n  * Measurable disease as defined by the 2014 Lugano Classification\n  * Availability of formalin-fixed paraffin-embedded tumor tissue block\n  * ECOG performance status 0 to 2\n  * Adequate organ function\n  * Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception from the time of giving informed consent until at least 10 months after the last dose of loncastuximab tesirine. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of giving informed consent the first dose until at least 7 months after the last dose of loncastuximab tesirine. Men must refrain from donating sperm during this same period. Arm E: WOCBP must agree to use contraceptive methods that result in a failure of less than 1% per year or remain abstinent (refrain from heterosexual intercourse) during the treatment period and for at least 18 months after pretreatment with obinutuzumab. Arm F: WOCBP must agree to use contraceptive methods that result in a failure of less than 1% per year or remain abstinent (refrain from heterosexual intercourse) during the treatment period and for at least 3 months after the final dose of mosunetuzumab and tocilizumab (if applicable)\n  * Patients 80 years of age and older at the time of signing the informed consent must be deemed fit by Cumulative Illness Rating Scale - Geriatric (CIRS-G scale), defined as no score of 3-4 in any category AND \\\u003C 5 categories with a score of 2 excluding hematologic criteria\n\nExclusion Criteria:\n\n* Known history of hypersensitivity resulting in treatment discontinuation to or positive serum human ADA to a CD19 antibody\n* Previous therapy with loncastuximab tesirine\n* Previous treatment with polatuzumab vedotin, glofitamab or mosunetuzumab (applied to relevant arm and\u002For cohort of the specific drug administered)\n\n  * Participants who received previous treatment of polatuzumab vedotin containing regimen will be excluded from Arm C\n  * Participants who received previous treatment of glofitamab containing regimen will be excluded from Arm E\n  * Participants who received previous treatment of mosunetuzumab containing regimen will be excluded from Arm F\n* Human immunodeficiency virus (HIV) seropositive\n* Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load\n* Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load\n* History of confirmed progressive multifocal leukoencephalopathy\n* History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or macrophage activation syndrome (MAS)\u002Fhemophagocytic lymphohistiocytosis (HLH)\n* Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)\n* Breastfeeding or pregnant\n* Significant medical comorbidities\n* Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy, within 14 days prior to start of study drugs (C1 D1), unless approved by the Sponsor\n* Live vaccine within 4 weeks prior to C1D1\n* Failure to recover to Grade ≤1 (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5.0) from acute non-hematologic toxicity (excluding alopecia) due to previous therapy prior to screening\n* Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree and document should not be exclusionary\n\nExtra Exclusion Criteria for Arms E (includes glofitamab) and F (includes mosunetuzumab) Note: as applicable, the arm-specific exclusion criteria may supersede the general ones, such as stem cell transplant.\n\n* Prior allogeneic stem cell transplant and solid organ transplant\n* Autologous stem cell transplant within 100 days prior to C1D1\n* History of central nervous system (CNS) lymphoma or leptomeningeal infiltration\n* Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n* Known active infection, reactivation of a latent infection, whether bacterial, viral, fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within four weeks prior to C1D1\n* Active or history of autoimmune disease or immune deficiency, motor neuropathy considered of autoimmune origin and other CNS autoimmune diseases, including but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with, with certain exceptions\n* Prior treatment with anti-cancer\u002Flymphoma targeted therapies (e.g., tyrosine kinase inhibitors, systemic immunotherapeutic\u002Fimmunostimulating agents, including, but not limited to, cluster of differentiation 137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death protein 1 (PD1), and anti-programmed death ligand 1 (PDL1) therapeutic antibodies, radio-immunoconjugates, ADCs, immune\u002Fcytokines and monoclonal antibodies) or treatment with systemic immunosuppressive medication (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to C1D1, or anticipation of need for systemic immunosuppressive medication during study treatment, with certain exceptions\n* Prior treatment with CAR-T-cell therapy within 100 days prior to C1D1; primary refractory patients (progressive or persistent disease within 30 days) to CAR-T-cell therapy are not eligible\n* Toxicities from prior anti-cancer therapy including immunotherapy that did not resolve to ≤ Grade 1 with the exception of alopecia, endocrinopathy managed with replacement therapy and stable vitiligo\n* Any history of immune-related Grade ≥3 AE with the exception of endocrinopathy managed with replacement therapy\n* Ongoing corticosteroid use greater than 25 mg\u002Fday of prednisone or equivalent within 4 weeks prior and during study treatment\n* Administration of a live attenuated vaccine within 4 weeks prior to the first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study or within 5 months after last dose of study treatment\n* Arm E only: Known history of hypersensitivity to obinutuzumab",{"count":242,"type":21},200,[24],"The primary objective of this study is to characterize the safety and tolerability of loncastuximab tesirine in combination with polatuzumab vedotin, glofitamab, or mosunetuzumab, and to identify the maximum tolerated dose (MTD) and\u002For recommended dose for expansion (RDE) for the combinations.",[108,246,247],"Relapsed B-Cell Non-Hodgkin Lymphoma","Refractory B-Cell Non-Hodgkin Lymphoma",[108,246,247,249],"Loncastuximab Tesirine","2026-06-07",{"date":154,"type":37},{"date":253,"type":37},"2022-06-17",{"date":255,"type":21},"2027-10-29",{"name":257,"class":44},"ADC Therapeutics S.A.",42,{"id":260,"slug":4,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":22,"phases":267,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":117},"100583670","NCT06879340","Evaluating the Safety and Efficacy of DuoCAR20.19.22-D95 in Adult Patients With Relapsed or Refractory B-cell Malignancies","A Phase 1 Multicenter, Open Label Trial Evaluating the Safety and Efficacy of DuoCAR20.19.22-D95 in Adult Patients With Relapsed or Refractory B-cell Malignancies","Inclusion Criteria:\n\n1. Ability of participant to understand this study, and participant willingness to sign a written informed consent\n2. Women of childbearing potential must have a negative serum pregnancy test 48 hours prior to the start of preparatory regimen\n3. Patients must have histologically confirmed aggressive B-Cell NHL or ALL as stated below:\n\n   A. Patients with relapsed or refractory B-Cell ALL i. Demonstration of one or more antigens of interest (CD19, CD20, CD22) in most recent disease evaluation prior to study entry and within 30 days of study entry.\n\n   ii. Patients with relapsed\u002Frefractory disease in blood, marrow, and extramedullary sites including CSF will be eligible when there is immunophenotypic evidence of CD19 and\u002For CD20 and\u002For CD22 expression\n\n   iii. Primary refractory disease at study entry defined as: A morphologic complete response has never been achieved prior to study entry.\n\n   iv. Early first relapse at study entry defined as: Disease recurrence by morphologic assessment after duration of first remission at ≤ 18 months\n\n   v. Relapsed Refractory disease (first or later relapse) at study entry defined as: Morphologic complete response was not achieved after initiation of a second-line (or later) systemic therapy\n\n   vi. Second or greater relapse at study entry defined as: Any disease recurrence following a second or later complete response (with treatment history including two or more lines of systemic therapy)\n\n   vii. Additional considerations beyond above criteria:\n   * Patients with relapsed or refractory disease after allogeneic stem cell transplantation must be \\>100 days from HSCT to be eligible for study participation. Furthermore, post-HSCT immunosuppressive medications must be discontinued for at least 4 weeks prior to study entry\n   * Prior CAR-T therapy is permissible if ≥ 3 months from therapy completion\n   * Morphological disease in the bone marrow Note: Morphologic disease is defined as blasts being at least 5% in the bone marrow.\n\n   B. Histologically confirmed aggressive B cell NHL, including the following types defined by WHO 2008 after 2 or more lines of prior therapy:\n\n   i. DLBCL not otherwise specified; T cell\u002Fhistiocyte rich large B cell lymphoma; DLBCL associated with chronic inflammation; Epstein-Barr virus (EBV)+ DLBCL of the elderly; Primary cutaneous DLBCL, leg type; OR ii. Primary mediastinal (thymic) large B cell lymphoma iii. Follicular lymphoma 3b and transformation of follicular lymphoma to DLBCL will also be included iv. High-grade B cell lymphoma v. Chemotherapy-refractory disease, defined as one or more of the following:\n   * Refractory disease is defined as progressive or stable disease as the best response to the most recent prior therapy or relapse within 12 months of autologous stem cell transplantation. Two prior lines of therapy are required for LBCL eligibility. The second line therapy may be chemotherapy based, autologous stem cell transplantation, or CAR-T.\n   * Relapsed or refractory disease after allogeneic transplant provided patient is at least 100 days from stem cell transplant at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment\n   * Patients must have received 2 or more lines of adequate prior therapy including at a minimum:\n\n     * anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20- negative and\n     * an anthracycline containing chemotherapy regimen\n     * for patients with transformed FL must have received prior chemotherapy for follicular lymphoma and subsequently have chemorefractory disease after transformation to DLBCL vi. Prior CAR T therapy permissible if ≥ 3 months from the therapy vii. At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma (Cheson 2007). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy C. Relapsed or refractory indolent non-Hodgkin lymphoma i. Histologically confirmed indolent non-Hodgkin lymphoma, including grade 1-3b follicular lymphoma or nodal or extranodal marginal zone lymphoma (both per WHO 2016 classification criteria) ii. Relapsed or refractory disease (per Lugano criteria) after two or more previous lines of therapy, iii. Previous lines of therapy to include an anti-CD20 monoclonal antibody combined with an alkylating agent iv. Prior CAR T therapy permissible if ≥ 3 months from the therapy v. At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma (Cheson 2007). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy vi. Relapsed or refractory disease after allogeneic transplant provided patient is at least 100 days from stem cell transplant at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment D. Relapsed or Refractory Mantle-Cell Lymphoma i. Histologically confirmed mantle-cell lymphoma with either cyclin D1 overexpression or presence of the translocation (T11:14) ii. Disease that is either relapsed or refractory to at least 2 prior lines of previous regimens for mantle-cell lymphoma iii. Previous therapy must have included anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 monoclonal antibody, and BTK inhibitor therapy\n4. Prior CAR T therapy permissible if ≥ 3 months from the therapy\n5. At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma (Cheson 2007). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy\n6. Relapsed or refractory disease after allogeneic transplant provided patient is ≥ 3 months from stem cell transplant at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment\n7. Meet institutional criteria for leukapheresis procedure or have availability of previously- collected and stored leukapheresis product that satisfies minimum requirements\n8. Eastern cooperative oncology group (ECOG) performance status of 0 to 2.\n9. Adequate hematologic and organ function NOTE: Patients with established diagnosis of benign neutropenia are eligible to participate with ANC between 1000-1500 if in the opinion of treating physician the trial treatment does not pose excessive risk of infection to the patient.\n10. Adults ≥ 18 years of age, with no upper limit of age\n11. Life expectancy \\>2 months\n12. ≥ 3 months from prior CAR\n13. Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential\u002FPregnancy section from the time of signing informed consent to at least 12 months following DuoCAR20.19.22-D95 infusion and until CAR positive viable T cells are no longer present by quantitative polymerase chain reaction (qPCR) on two consecutive tests. Men must agree not to donate sperm for the same time period.\n\nExclusion Criteria:\n\n1. Patients with CLL, Richter's transformation, and Burkitt lymphoma\n2. Active CNS involvement by malignancy - CNS3 disease, i.e., patients with WBC count in CSF ≥5 and having blasts in the CSF in patients with ALL or detection of NHL on CSF by flow cytometry or active CNS involvement on imaging)\n3. Chemotherapy other than lymphodepleting chemotherapy within 2 weeks of infusion\n4. Investigational medicinal product within the last 30 days prior to screening Note: Investigational therapies must not be used at any time while on study until the first progression following DuoCAR20.19.22-D95 CAR T infusion.\n5. The following medications are excluded:\n\n   1. Steroids: Therapeutic doses of steroids must be stopped \\> 72 hours prior to leukapheresis and \\> 72 hours prior to DuoCAR20.19.22-D95 infusion. However, the following physiological replacement doses of steroids are allowed: \\\u003C12 mg\u002Fm2\u002Fday hydrocortisone or equivalent\n   2. Immunosuppression: Any other immunosuppressive medication must be stopped ≥ 2 weeks prior to leukapheresis and ≥ 2 weeks prior to DuoCAR20.19.22-D95 infusion. This could include check point inhibitors (monoclonal antibodies and small molecule modulators).\n   3. Antiproliferative therapies other than lymphodepleting chemotherapy within 2 weeks prior to infusion\n   4. Short acting drugs used to treat leukemia or lymphoma (e.g., tyrosine kinase inhibitors, and hydroxyurea) must be stopped \\> 72 hour prior to leukapheresis and \\> 72 hours prior to DuoCAR20.19.22-D95 infusion\n   5. Other cytotoxic drugs, including low dose daily or weekly maintenance chemotherapy, must not be given within 2 weeks prior to leukapheresis and within 2 weeks prior to DuoCAR20.19.22-D95 infusion.\n   6. Antibody use including anti-CD20 therapy within 4 weeks prior to infusion or 5 half-lives of the respective antibody, whichever is longer. Note: Rituximab is excluded within 4 weeks prior to infusion.\n   7. CNS disease prophylaxis or treatment must be stopped \\> 1 week prior to DuoCAR20.19.22-D95 infusion (e.g., intrathecal methotrexate)\n6. Prior radiation therapy within 2 weeks of infusion\n7. Active replication of or prior infection with hepatitis B or active hepatitis C (HCV RNA positive)\n8. HIV positive patients (excluding false positive HIV test resulting from the viral vector used in prior CAR T)\n9. Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g., blood culture positive ≤ 72 hours prior to infusion)\n10. Unstable angina and\u002For myocardial infarction within 6 months prior to screening\n11. Previous or concurrent malignancy with the following exceptions:\n\n    1. Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)\n    2. In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study\n    3. A primary malignancy which has been completely resected and in complete remission for ≥ 5 years\n12. Simultaneously enrolled in any therapeutic clinical trial (except for long-term follow up studies)\n13. Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study\n14. Either diagnosed with a psychiatric illness or under the impact of a social situation that would limit compliance with study requirements in the opinion of the investigator\n15. Is pregnant or breastfeeding\n16. Intolerance to the excipients of the cell product\n17. Cardiac arrhythmia not controlled with medical management\n18. Active COVID-19 (follow ASTCT guidelines)\n19. Presence of active grade 2 to 4 acute, extensive chronic graft-versus-host disease (GVHD) or that require systemic steroids\n20. Patients with active neurological auto immune or inflammatory disorders (e.g., Guillain-Barré Syndrome, Amyotrophic Lateral Sclerosis)",{"count":266,"type":21},54,[24],"This multicenter phase 1 trial with \"3 + 3\" dose escalation design seeks to examine the feasibility and safety of the administration of autologous T cells that have been modified through the introduction of chimeric antigen receptors targeting the B cell surface antigens CD19\u002F20\u002F22 following administration of a chemotherapy lymphodepletion regimen in adults with relapsed\u002Frefractory B-cell acute lymphoblastic leukemia (ALL) or Non-Hodgkin's lymphoma (NHL). The overall goals of this study are to estimate maximum tolerated dose (MTD) level, establish the overall safety profile and evaluate initial efficacy of administering duo-CAR-T cell treatment in this patient population.",[108,270],"B-cell Acute Lymphoblastic Leukemia","2026-05-11",{"date":273,"type":37},"2026-05-14",{"date":275,"type":37},"2025-03-31",{"date":277,"type":21},"2040-03",{"name":279,"class":163},"University of Kansas Medical Center",{"id":281,"slug":4,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":22,"phases":288,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":4},"100639067","NCT07584850","Evaluation of GI001 for Relapsed or Refractory B-cell Non-Hodgkin Lymphoma","An Exploratory Clinical Study to Evaluate the Safety and Efficacy of GI001 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (r\u002Fr B-NHL)","Inclusion Criteria:\n\n1. Age: 18 years and older (inclusive).\n2. Diagnosis: Diagnosis of CD19-positive relapsed\u002Frefractory B-cell lymphoma\u002Fleukemia:\n\n   * 1\\) CD19-positive relapsed or refractory B-cell lymphoma\u002Fleukemia must meet the following criteria:\n   * Histopathological diagnosis includes: indolent lymphoma (iNHL), including but not limited to follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), lymphoplasmacytic lymphoma (LPL), hairy cell leukemia (HCL), etc.; aggressive B-cell lymphoma, including but not limited to diffuse large B-cell lymphoma (DLBCL, including Richter-transformed DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), lymphoblastic lymphoma (LBL), transformed follicular lymphoma (TFL), and T-cell\u002Fhistiocyte-rich large B-cell lymphoma (TCRBCL), etc., and patients in the lymphoma leukemia phase involving the bone marrow.\n   * Definition of refractory: Best response to first-line standard therapy is PD; or response to first-line therapy is SD for 6 months after at least 4 cycles; or no response to second-line or later therapies, including PD as best response to the most recent therapy; or SD for 6 months after at least 2 cycles of the most recent therapy; or disease progression or biopsy-confirmed relapse within 12 months after autologous hematopoietic stem cell transplantation (ASCT); or patients undergoing salvage therapy after ASCT with no remission or relapse (SD or PD) after the last treatment; or relapse more than 3 months after CAR-T cell therapy in CD19+ patients.\n   * Definition of relapse: PD again after achieving remission (including PR or CR) following adequate treatment.\n   * Note: Subjects must have been adequately treated and failed or relapsed after guideline-recommended first-line therapy (including anti-CD20 monoclonal antibody combination therapy or BTK inhibitors).\n   * 2\\) B-cell lymphoma\u002Fleukemia patients with bone marrow relapse must meet the following criteria:\n   * Definition of relapse: Hematological relapse: re-emergence of B-lymphoma cells ( 5%) in peripheral blood or bone marrow in patients who achieved CR, or appearance of extramedullary disease; OR bone marrow or peripheral blood molecular relapse: MRD positivity reappears after HCR and MRD negativity, with an increase of 1 log in MRD levels between two positive samples.\n   * Definition of refractory: Failure to achieve CR after at least two cycles of standard chemotherapy; or failure to achieve CR after at least one cycle of treatment following late relapse ( 12 months) after CR; or relapse after HSCT; or patients undergoing salvage therapy after HSCT failing to achieve remission after the last treatment; or Philadelphia chromosome-positive patients who failed to achieve CR or relapsed after at least two types of TKI treatment, or are intolerant\u002Fcontraindicated to TKI treatment.\n   * 3\\) Patients unsuitable for stem cell transplantation, or with documented refusal of other existing treatments, or for whom no standard treatment plan exists, may also be included.\n3. CD19 expression: CD19 positivity detected by IHC or FACS in tumor specimens, bone marrow, or peripheral blood during screening.\n4. Measurable disease: B-cell lymphoma subjects must have measurable lesions per Lugano 2014 (LDi \\> 1.5 cm for nodal, LDi \\> 1.0 cm for extranodal); B-lymphoma\u002Fleukemia subjects must have B-lymphoma cell proportion 5% at screening.\n5. ECOG performance status: 0-2.\n6. Life expectancy: 12 weeks.\n7. Organ function: Adequate organ function meeting the following laboratory results before enrollment:\n\n   * Blood routine: For B-cell lymphoma patients, bone marrow reserve must meet: ANC \\> 0.5 10E9\u002FL (no short-acting G-CSF within 7 days or long-acting G-CSF within 14 days); ALC 0.5 10E9\u002FL; Platelets 30 10E9\u002FL (no transfusion within 7 days); Hemoglobin 80 g\u002FL (no RBC transfusion within 7 days; EPO allowed). All patients (B-cell lymphoma\u002Fleukemia) require absolute CD3+ T-cell count 150\u002FL.\n   * Liver function: ALT and AST 3 ULN; Total bilirubin 2 ULN.\n   * Renal function: CrCl 60 ml\u002Fmin (Cockcroft-Gault).\n   * Coagulation: Fibrinogen 1.0 g\u002FL; APTT 1.5 ULN; PT 1.5 ULN.\n   * Heart: LVEF 55%.\n   * Oxygen saturation: \\> 91%.\n8. Steroids: Therapeutic doses of steroids must be stopped 72 hours before GI001 infusion (except physiological replacement doses).\n9. CNS prophylaxis: Must be stopped 1 week before GI001 infusion (e.g., intrathecal methotrexate).\n10. Contraception: Subjects and spouses agree to use effective contraception from signing ICF until one year after GI001 infusion or until CAR-T cells are not detected in two consecutive PCR tests (whichever is longer).\n11. Informed Consent: Voluntarily sign the EC-approved ICF before screening.\n\nExclusion Criteria:\n\n1. Prior antitumor therapy (except drugs proven to enhance or not affect CAR-T efficacy after elution):\n\n   * Cytotoxic chemotherapy within 2 weeks before administration.\n   * Small molecule targeted therapy within 2 weeks before administration.\n   * Antibody therapy within 3 weeks before administration.\n   * PEG-asparaginase within 4 weeks before administration.\n   * Immunosuppressive therapy within 4 weeks before administration or requirement for long-term use.\n   * Radiotherapy within 4 weeks before administration.\n   * Bendamustine within 6 months before administration.\n   * Previous gene therapy products, including CAR-T therapy (except patients with no CAR-T in vivo, normal T-cell count\u002Ffunction, and CD19+ tumor).\n   * Previous anti-CD19\u002Fanti-CD3 or any other anti-CD19 therapy (except patients with normal T-cell count\u002Ffunction and CD19+ tumor).\n   * Other interventional clinical trial drugs or antitumor therapies within 4 weeks or 5 half-lives before administration (whichever is shorter).\n2. Other malignancies: Malignancies within 2 years before screening, excluding adequately treated cervical carcinoma in situ, skin cancers, or radically treated localized prostate, breast (DCIS), or papillary thyroid cancers.\n3. Organ transplant: History of solid organ transplantation.\n4. Immunomodulators: Use within 2 weeks before administration or potential use during the study (e.g., thalidomide, lenalidomide, pomalidomide).\n5. Corticosteroids: Requirement for long-term therapeutic doses (Prednisone \\> 15 mg\u002Fday or equivalent), except physiological replacement or topical\u002Finhaled use.\n6. CNS involvement: History or presence of CNS infiltration (leukemia\u002Flymphoma cells in CSF; imaging showing masses\u002Fenhancement; or neurological symptoms with abnormal CSF).\n7. Hypertension: Uncontrolled hypertension despite drug therapy.\n8. Cardiac disease: Severe cardiac disease: MI or CABG\u002Fstenting within 6 months; unstable angina; NYHA Class III heart failure; severe arrhythmia; severe non-ischemic cardiomyopathy.\n9. Systemic disease: Unstable systemic disease: severe liver, kidney, or metabolic disease requiring medication.\n10. Infection: Uncontrolled active infection (bacterial, fungal, viral) requiring IV anti-infectives (continuous signs\u002Fsymptoms without improvement).\n11. Neurological\u002FPsychiatric: Stroke or epilepsy within 6 months; other CNS diseases; uncontrolled psychiatric disorders; history deemed to increase risk or interfere with results.\n12. Thrombosis: History of DVT or PE within 6 months.\n13. Vaccine: Live vaccine within 6 weeks before screening.\n14. Surgery: Major surgery within 2 weeks before screening or planned surgery within 2 weeks after administration (except local anesthesia).\n15. Pregnancy\u002FLactation: Pregnant or nursing women, or those planning pregnancy during\u002Fafter treatment.\n16. Toxicity: Prior non-hematological toxicities not resolved to baseline or Grade 2 (except alopecia, fatigue, peripheral neuropathy).\n17. Viral pseudotyping: Prior treatment using VSV-G or Nipah virus pseudotyping.\n18. Infectious serology: HBsAg+ and\u002For HBcAb+ with HBV-DNA \\> detection limit; HCV antibody+ with HCV-RNA \\> detection limit; HIV antibody+; Syphilis serology+.\n19. Extramedullary relapse: B-cell leukemia patients with isolated extramedullary relapse.\n20. Allergy: Allergy to the study drug, excipients, or Tocilizumab.\n21. Immunodeficiency: Patients with primary immunodeficiency.\n22. HSCT: Planned HSCT within 28 days after GI001 injection.\n23. Other: Other conditions deemed unsuitable by the investigator.",{"count":287,"type":21},9,[289],"EARLY_PHASE1","The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary efficacy in adult patients with relapsed or refractory (r\u002Fr) CD19-positive B-cell Non-Hodgkin Lymphoma (B-NHL) or B-cell Leukemia. The main questions it aims to answer are:\n\n* What are the safety and tolerability profiles of GI001, specifically regarding the incidence of Dose-Limiting Toxicities (DLTs) and the determination of the Maximum Tolerated Dose (MTD)?\n* What is the preliminary efficacy of GI001, measured by Objective Response Rate (ORR), Complete Response Rate (CRR), and Duration of Response (DOR)?\n* What are the pharmacokinetic (expansion and persistence of CAR-T cells) and pharmacodynamic (cytokine changes) characteristics of GI001?\n\nParticipants will:\n\n* Undergo a screening process (D-30 to D-3) and baseline evaluation to ensure eligibility, including confirmation of CD19-positive disease.\n* Receive a single intravenous infusion of GI001 at one of four designated dose levels (1E8, 3E8, 7E8 or 1E9 TU) following an \"Accelerated Titration\" and \"3+3\" dose-escalation design.\n* Remain hospitalized for at least 14 days post-infusion for intensive safety monitoring, specifically for Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).\n* Provide multiple blood, saliva, and urine samples for pharmacokinetic (PK), pharmacodynamic (PD), and exploratory analysis (including immunogenicity and viral shedding).\n* Participate in efficacy and safety follow-ups through Month 24, followed by a long-term safety follow-up for up to 15 years.",[108],"2026-05-07",{"date":294,"type":37},"2026-05-13",{"date":296,"type":21},"2026-04-20",{"date":298,"type":21},"2029-04-20",{"name":300,"class":163},"Ruijin Hospital",{"id":302,"slug":4,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":22,"phases":309,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":117},"100600428","NCT07097363","Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for the Treatment of Aggressive B-Cell Non-Hodgkin Lymphoma","A Pilot Study of Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for Upfront Treatment of Aggressive B-Cell Non-Hodgkin Lymphomas","Inclusion Criteria:\n\n* Untreated aggressive large-B cell lymphoma (non-Hodgkin lymphoma) with adverse features that may predict sub-optimal response to R-CHOP and in the opinion of the investigator would be treated with dose adjusted (DA)-EPOCH-R as standard of care. Subjects must be planned to receive full course (6 cycles) chemoimmunotherapy as per clinical standard of care. 1 prior cycle of chemoimmunotherapy may be allowed. Composite lymphomas are not excluded provided that the subject has not received prior systemic therapy for the indolent component and would receive DA-EPOCH-R as the standard of care regimen for the aggressive component. Eligible histologies based on 2016 World Health Organization (WHO) classification include:\n\n  * High grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 translocations\n  * High grade B-cell lymphoma, not otherwise specified (NOS)\n  * Diffuse large b-cell lymphoma (DLBCL) NOS\n  * Primary mediastinal B-cell lymphoma\n  * T-cell\u002Fhistiocyte-rich large-B-cell lymphoma\n  * Epstein Barr virus (EBV) + DLBCL, NOS\n  * Burkitt lymphoma\n  * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma\n* Be willing and able to provide written informed consent for the trial\n* Be ≥ 18 years of age on day of signing informed consent\n* Have measurable disease, including at least 1 nodal site measuring 1.5 cm or 1 extranodal site measuring 1.0 cm in longest dimension on CT or FDG-PET\n* Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale (PS) at time of enrollment\n* Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)\n* Absolute neutrophil count (ANC) ≥ 1,000\u002FμL except in cases of marrow infiltration by lymphoma\n* Platelets ≥ 75,000 \u002F mcL except in cases of marrow infiltration by lymphoma or hypersplenism\n* Hemoglobin ≥ 8 g\u002FdL except in cases of marrow infiltration by lymphoma without red blood cell (RBC) transfusion within 14 days of first treatment\n* Measured or calculated\\* creatinine clearance (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine clearance \\[CrCl\\]) ≥ 45 mL\u002Fmin\n\n  * Creatinine clearance should be calculated per institutional standard\n* Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) (Patients with documented Gilbert disease may be enrolled if total bilirubin ≤ 3.0 x ULN) OR direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver involvement\n* International Normalized Ratio (INR) ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants or prothrombin Time (PT) ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of ≤ 1% per year during the treatment period and for at least 12 months after the last dose of study treatment. Women must refrain from donating eggs during this same period. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (≤ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements. Examples of contraceptive methods with a failure rate of ≤ 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception\n* For women of childbearing potential, a negative serum pregnancy test result during screening period. Women who are considered not to be of childbearing potential are not required to have a pregnancy test\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the last treatment. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of preventing drug exposure. Male patients considering preservation of fertility should bank sperm before study treatment\n\nExclusion Criteria:\n\n* Contraindication to any of the individual components of EPOCH-R, including, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products or if receiving an additional 6 cycles of anthracycline would place patient over the anthracycline lifetime cumulative dose (400 mg\u002Fm\\^2)\n* Prior systemic treatment for lymphoma. Prior radiotherapy is allowed provided that this site is not used as a measurable site to assess response\n* Transformation from indolent lymphoma is allowed provided that the subject has not received prior systemic therapy for their lymphoma and the aggressive component meets one of the criteria listed in inclusion criterion\n* Prior organ transplantation\n* Current grade \\> 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease\n* Prior systemic therapy for indolent lymphoma\n* Prior therapy for large B-cell lymphoma except for patients who require lymphoma symptom control during screening may receive steroids and\u002For 1 cycle of chemoimmunotherapy in the following manner:\n\n  * Up to 30 mg\u002Fday of prednisone or equivalent may be used for lymphoma symptom control during screening, including prior to finalization of staging (not included as part of pre-phase treatment). If glucocorticoid treatment is urgently required at higher doses for lymphoma symptom control prior to the start of study treatment, tumor assessments must be completed prior to initiation of \\> 30-100 mg\u002Fday of prednisone or equivalent. Prednisone \\> 30-100 mg\u002Fday or equivalent may be given for a maximum of 7 days as a pre-phase treatment. If patients exceed the allowed dosing of corticosteroids, patients may still be eligible for the study provided that baseline imaging is performed (or repeated) after completion of the course of higher dose of steroids. Allowed corticosteroid dosing resets from the point of imaging forward and patients who do not exceed the allowed corticosteroid dosing from the point of imaging until initiation of study treatment may enroll. A maximum of 1 cycle of chemoimmunotherapy is allowed if needed for urgent disease stabilization if patient had staging PET\u002FCT and LVEF evaluation prior to chemoimmunotherapy; in this situation patients will receive therapy on study starting with cycle (C)1 day (D)8 epcoritamab provided the next cycle of EPOCH-R chemotherapy will not be delayed by \\> 7 days. In this situation, the date of receiving the first dose of EPOCH-R is considered C1D1 of the study treatment. Labs collected prior to C1D1, in accordance with SOC for the administration of these drugs, can be used for screening purposes\n* History of other malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. The following are eligible without a specific waiver:\n\n  * Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible.\n  * Patients with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment are eligible.\n  * Patients with low-grade, early-stage prostate cancer (Gleason score 6 or below, stage 1 or 2) with no requirement for therapy at any time prior to study are eligible\n* Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)\n* Recent major surgery (within 4 weeks prior to the start of cycle 1), other than for diagnosis\n* History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third degree heart block, or evidence of prior myocardial infarction in the last 6 months\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) which requires systemic treatment. Patients may proceed with screening during treatment for infection, but systemic treatment must be completed by cycle 1 day 1.\n\n  * If a subject has signs\u002Fsymptoms suggestive of SARS-CoV-2 infection, the subject must have a negative molecular (e.g., polymerase chain reaction \\[PCR\\]) test or 2 negative antigen test results at least 24 hours apart. Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen-failed and may only rescreen if the following have been met:\n\n    * At least 10 days since first positive test result have passed in asymptomatic patients or at least 10 days since recovery, defined as resolution of fever without use of antipyretics and improvement in symptoms\n* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology):\n\n  * Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening. These patients must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated by institutional standard\n* Positive test results for hepatitis C (hepatitis C virus \\[HCV\\] antibody serology testing)\n\n  * Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)\n* History of uncontrolled HIV\n\n  * Patients with known diagnosis of HIV must have undetectable viral load and be on anti-retroviral therapy\n* Patients with a history of progressive multifocal leukoencephalopathy\n* Patients with known active central nervous system lymphoma\n* Patients needing a treatment regimen which would require use of mid-cycle high dose IV methotrexate for central nervous system (CNS) prophylaxis in the opinion of the treating provider\n* Pregnancy or lactation or intending to become pregnant during study",{"count":308,"type":21},18,[25],"This phase II trial tests the safety, best dose, and effectiveness of epcoritamab when given with etoposide, cyclophosphamide, vincristine, doxorubicin, prednisone and rituximab (EPOCH-R) for the treatment of patients with aggressive B-cell non-Hodgkin lymphoma. Epcoritamab is a bispecific antibody that can bind to two different antigens at the same time. Epcoritamab binds to CD3, a T-cell surface antigen, and CD20 (a tumor-associated antigen that is expressed on B-cells during most stages of B-cell development and is often overexpressed in B-cell cancers) and may interfere with the ability of cancer cells to grow and spread. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. The EPOCH-R is administrated as the standard of care treatment. This may help the immune system kill cancer cells. Giving epcoritamab with EPOCH-R may be safe, tolerable, and effective in treating patients with aggressive B-cell non-Hodgkin lymphoma.",[108,312,313,314,315,316,317,318,319],"Burkitt Lymphoma","Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","High Grade B-Cell Lymphoma With MYC and BCL2 and\u002For BCL6 Rearrangements","High Grade B-Cell Lymphoma, Not Otherwise Specified","Primary Mediastinal Large B-Cell Lymphoma","T-Cell\u002FHistiocyte-Rich Large B-Cell Lymphoma","Transformed B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma to Diffuse Large B-Ce","2026-04-21",{"date":322,"type":37},"2026-04-23",{"date":324,"type":37},"2025-12-07",{"date":326,"type":21},"2030-05-31",{"name":328,"class":163},"University of Washington",{"id":330,"slug":4,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":17,"minAge":335,"maxAge":336,"enrollmentInfo":337,"targetDuration":4,"studyType":22,"phases":339,"briefSummary":340,"conditions":341,"keywords":342,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":117},"100404304","NCT04544592","UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL","Phase I\u002FII Dose Escalation and Preliminary Efficacy of CD19 Directed CAR-T Cells Generated Using the Miltenyi CliniMACs Prodigy System (UCD19 CAR-T) in Pediatric Patients With Relapsed and\u002For Refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL) and B-Cell Non-Hodgkin Lymphoma (B-NHL)","Inclusion Criteria:\n\n* Meets clinical criteria for leukapheresis or has a leukapheresis product previously collected and stored per recommended guidelines.\n* Provision of signed and dated consent form from parent or guardian (patients \\\u003C18), the patient themselves (\\>18), or legally authorized representative (patient \\>18 who lack decision-making capacity); Pediatric patients will be included in age-appropriate discussions and assent will be obtained for those \\> 7 years of age, when appropriate, according to institutional standards.\n* Willingness to participate in long term follow up study.\n* Stated willingness to comply with all study procedures and be available for the duration of the study.\n* Males OR non-pregnant, non-breastfeeding females.\n\n  o Patients of child-bearing potential or capable of fathering a child must agree to use highly effective contraception from the time of initial CAR T cell administration though 12 months following the final administration of investigational product.\n* Aged 31 days to 30 years (inclusive) at time of consent and enrollment.\n* Acute Lymphoblastic Leukemia (ALL) OR Non-Hodgkin Lymphoma (NHL) of B-cell origin that:\n\n  * Has confirmed expression of CD19 by flow cytometry, immunohistochemistry (IHC), or both.\n\nCohort One Criteria:\n\n* Meets any one of the following conditions:\n\n  * Relapsed two or more times\n  * Relapsed at any time after allogeneic BMT\n  * Refractory to standard therapy as determined by the treating physician\n  * Meets criteria for BMT but is ineligible as determined by the treating physician Patient and\u002For parents declining BMT options and would prefer CAR-T Therapy.\n* Non-Hodgkin Lymphoma includes all of the following:\n\n  * Diffuse large B-cell lymphoma (DLBCL)\n  * Burkitt Lymphoma\n  * Intermediate lymphoma between Burkitt and DLBCL\n  * Primary Mediastinal B-cell Lymphoma (PMBL)\n  * Follicular lymphoma\n  * High grade B cell lymphoma\n  * Transformed lymphoma\n\nCohort Two Criteria:\n\n* B-ALL in first relapse with any one of the following conditions:\n\n  * High-risk genomic alterations at initial diagnosis such as KMT2A gene rearrangement, t(17;19), hypodiploidy, Ph-like mutations, BCR-ABL1 fusion (Ph+ ALL), iAMP21, and TP53 inactivating mutation\u002Fdeletion.\n  * Isolated CNS relapse such that cranial radiation would be indicated as a component of standard salvage therapy.\n  * Down syndrome.\n  * Minimal residual disease (MRD) positivity of \\> 0.01% by FACS or \\> 0 clonal sequences by NGS in bone marrow post re-induction chemotherapy.\n  * Age 18 years or older. OR Newly diagnosed with persistent MRD ≥ 0.01% by flow cytometry in bone marrow at end of consolidation.\n* Performance score (Lansky or Karnofsky) of 50% or better;\n* Unable to or declined to receive commercially available CD19 CAR-T Therapy.\n\nExclusion Criteria:\n\n* Evidence of rapidly progressive disease without adequate salvage\u002Fbridging regimens as determined by the investigator.\n* Active Graft-versus-Host Disease (GvHD).\n* Active, uncontrolled, life-threatening infection that at the determination of the treating physician would preclude safe leukapheresis or tolerance of LD chemotherapy, cell infusion, or cytokine release syndrome.\n* Evidence of severe organ dysfunction as defined by:\n\n  * Myocardial dysfunction: Ejection fraction ≤ 40% or shortening fraction ≤ 28%, evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and clinically significant electrocardiogram (ECG) findings.\n  * Baseline oxygen saturation of ≤ 90% on room air\n  * Transaminases \\> 10x upper limit of normal (ULN) or bilirubin \\>2x the ULN, unless thought to be related to primary disease\n  * Estimated Cr clearance \\\u003C60 mL\u002Fmin\u002F1.73 m2 (if nuclear medicine GFR or other more specific testing exceeds this level than it can supersede the estimated clearance)\n* Post-pubertal females that are pregnant, planning to become pregnant, or unwilling to use birth control (includes abstinence) for the study duration.\n* Known HIV infection, or active Hepatitis B or active Hepatitis C infection.","31 Days","30 Years",{"count":338,"type":21},45,[24,25],"This phase I\u002FII trial will investigate a new CD19 directed CAR-T therapy manufactured locally with the goals to expedite infusion to wider patient inclusion that includes those who were previously excluded, such as pediatric patients with B-cell NHL and patients in primary relapse.",[270,149],[343,151,344,345,346,347,348,349],"CD19","pediatric","relapsed","refractory","B-ALL","B-NHL","Miltenyi CliniMACS Prodigy","2026-04-16",{"date":296,"type":37},{"date":353,"type":37},"2021-03-10",{"date":355,"type":21},"2026-07",{"name":357,"class":163},"University of Colorado, Denver",{"id":359,"slug":4,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":22,"phases":366,"briefSummary":367,"conditions":368,"keywords":370,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":117},"100493261","NCT05702853","Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19+ Relapsed\u002FRefractory NHL, CLL\u002FSLL","A Phase 1b Dose Escalation Study of Metabolically Fit CD19 Chimeric Antigen Receptor (CAR) T Cells With CD34 Selection Markers in Adult Patients With Relapsed or Refractory CD19 B-Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Inclusion Criteria:\n\nPatients eligible for study participation must meet all of the following criteria:\n\n1. Disease Related Criteria\n\n   Participants must have histologic confirmation of one of the following:\n   1. CD19+ aggressive non-Hodgkin lymphoma including any of the following subtypes\n\n      * Diffuse Large B-cell Lymphoma, not otherwise specified\n      * DLBCL, germinal-center B-cell type (GCB)\n      * DLBCL, activated B-cell type (ABC)\n      * T-cell histiocyte-rich B-cell lymphomas (THRBCL)\n      * Primary cutaneous DLBCL, leg type\n      * Intravascular large B cell lymphoma\n      * EBV+ DLBCL, NOS\n      * DLBCL associated with chronic inflammation\n      * HHV8+ DLBCL, NOS\n      * High grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangement(double hit lymphoma)\n      * High grade B-cell lymphoma, NOS\n      * Primary mediastinal B-cell lymphoma\n      * B-cell Lymphoma, unclassifiable with features intermediate between DLBCL and Hodgkin lymphoma, as well as with features intermediate between DLBCL and Burkitt lymphoma\n      * Follicular lymphoma grade 3B\n      * Transformation of indolent lymphoma (i.e. CLL, MZL, FL, Waldenstrom's lymphoma,etc) to -diffuse large B-cell lymphoma\n      * Burkitt Lymphoma\n      * Lymphomatoid granulomatosis\n   2. CD19+ indolent non-Hodgkin lymphoma including any of the following subtypes:\n\n      * Follicular lymphoma (grade 1-3A)\n      * Marginal zone lymphoma: Including splenic marginal zone lymphoma, nodal marginal zone lymphoma, and mucosa associated lymphoid tissue (MALT) lymphoma\n      * Waldenstrom's Macrogloublinemia\n      * Nodular lymphocyte predominant hodgkin lymphoma (with documented CD19 expression)\n   3. Mantle cell Lymphoma\n   4. Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)\n2. Prior Therapy Criteria Prior\u002FConcurrent Therapy Related Criteria (dependent upon subtype - see below)\n\n   1. Aggressive lymphoma: patients will qualify if any of the following scenarios are met below (radiation does not count as a line of therapy)\n\n      * Relapse or persistent disease after ≥ 2 lines of systemic therapy OR\n      * Refractory disease or relapse within 12 months of completion of 1st line systemic therapy OR\n      * Refractory disease or relapse ≥ 1 line of therapy but not a candidate for autologous stem cell transplant\n      * Patients with Burkitt lymphoma will qualify after ≥ 1 line of therapy regardless of the timing of relapse\n   2. Indolent lymphoma:\n\n      * Relapse or persistent disease after ≥ 2 lines of systemic therapy. (Neither single agent rituximab or radiation qualify as a line of therapy.)\n   3. Mantle cell lymphoma:\n\n      * Relapse or persistent disease after ≥ 1 line of systemic therapy. Neither single agent rituximab or radiation qualify as a line of therapy.\n   4. Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma\n\n      * Evidence of progression or intolerance after ≥ 2 lines of therapy. The following will qualify as a line of therapy for CLL\u002FSLL:\n\n        * systemic chemoimmunotherapy (e.g. BR, FCR, etc),\n        * BTK inhibitor, BCL-2 inhibitor,\n        * or PI3 Kinase inhibitor.\n        * Neither single agent rituximab\u002Fobinutuzumab or radiation qualify as a line of therapy.\n3. Clinical\u002FLaboratory Criteria\n\n   1. Participants must be at least 18 years old\n   2. Participants must have a performance status of 0-2 on the ECOG scale\n   3. Participants must have adequate caregiving support for CAR T-cell therapy as determined by the PI\u002FCo-I.\n   4. Participants must have measurable disease on cross section imaging by PET-CT and\u002For CT scans alone that is at least 1.5 cm in the longest diameter and measurable in two perpendicular dimensions as defined by IWG criteria. If participants with CLL do not have measurable disease on imaging, a bone marrow biopsy showing \\> 5% CLL involvement in the bone marrow will qualify for enrollment\n   5. Participants that have received prior CD19 targeted therapy in the past they must have a tissue biopsy after completion of CD19 targeted therapy noting CD19 expression by either flowcytometry or immunohistochemistry (IHC). CD19 expression must be sufficient per PI\u002FCo-I\n   6. Adequate organ function\n\n      * Bone marrow function as evidenced by the following (unless directly attributable to disease within the bone marrow) within 14 days prior to registration.\n\n        * Platelet count ≥ 50,000 cells\u002Fmm3\n        * ANC ≥ 750 cells\u002Fmm3\n        * Absolute lymphocyte count ≥ 150 cells\u002F mm3\n      * Hepatic function as evidenced by the following within 14 days prior to registration.\n\n        * Serum bilirubin ≤ 1.5 X ULN unless attributed to Gilbert's syndrome or hemolysis or lymphoma involvement\n      * Cardiac\n\n        * No clinically significant ECG findings per PI\u002FCo-I\n      * Pulmonary\n\n        * Oxygen saturation \\> 90% on room air\n      * Renal function as evidenced by the following within 14 days prior to registration.\n\n        * Serum creatinine ≤ 2 mg\u002FdL or creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 60 mL\u002Fmin\n   7. Participants with hepatitis B virus infection must have undetectable viral load and on suppressive therapy within 14 days prior to registration and no evidence of HBV related hepatic damage.\n   8. Participants with Hepatitis C infection must have complete eradication therapy completed, have no evidence of HCV related damage and have undetectable viral load within 14 days of registration.\n   9. Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti- retroviral therapy and have an undetectable viral load test within 14 days prior to registration.\n   10. WOCBP should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment. All men and women of childbearing potential must use acceptable methods of birth control throughout the study as described below. FCBP must have negative serum or urine pregnancy within 7 days prior to registration.\n   11. Men with female partners who are of childbearing potential: Recommendations for male and partner to use at least two effective contraceptive methods, as described above, during the study.\n   12. Participants are able to understand and voluntarily sign consent prior to any study related assessments or procedures are performed.\n\nExclusion Criteria:\n\nParticipants eligible for study participation CANNOT meet any of the following criteria:\n\n1. Prior\u002FConcurrent Therapy Related Criteria Guidelines regarding when lymphoma directed therapy should be stopped prior to leukapheresis, lymphodepleting chemotherapy, and CAR T-cell infusion are detailed in the protocol. These criteria must be planned to be met for all patients.\n2. Clinical\u002FLaboratory Criteria\n\n   1. Women who are pregnant or breast-feeding.\n   2. Participants with active CNS lymphoma. Participants can have a history of active CNS lymphoma as outline in protocol\n   3. Participants with evidence of Graft vs Host Disease from allogeneic stem cell transplant are ineligible unless it is either grade 1 involvement of the skin or not requiring systemic immunosuppression.\n   4. Participants with uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs\u002Fsymptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy and\u002For other treatment)\n   5. Participants with a history of stroke or intracranial hemorrhage within 6 months prior to registration. Any CNS disorder that would serve as a major barrier in evaluating neurotoxicity\u002FICANS per enrolling physician\n   6. Participants with prior history of malignancy other than lymphoma unless subject is free of disease for more than 1 year from signing consent. Exceptions include the following:\n\n      * Basal cell carcinoma of the skin\n      * Squamous cell carcinoma of the skin\n      * Carcinoma in situ of the cervix or breast\n      * Previously treated localized prostate cancer with normal PSA levels\n   7. Participants with primary immunodeficiency or history of autoimmune disease (e.g. Crohn's, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 1 year.\n   8. Participants with receipt of live vaccine within 28 days prior to registration.\n   9. Participants with history of autologous stem cell transplant within the last 60 days or allogeneic stem cell transplant within the last 90 days or CAR T-cell therapy within the last 180 days.\n   10. Participants with a history of severe immediate hypersensitivity reaction to any of the agents used in the study\n   11. Participants with any other illness that in the opinion of the investigator, would exclude the patient from participating in this study.\n   12. Participants must not have evidence of active CNS lymphoma involvement. This includes parenchymal, spinal cord, meningeal, or cerebrospinal fluid involvement. Patients with history of CNS involvement must have documented remission by contrast-enhanced MRI imaging and CSF evaluation for at least 60 days prior to registration.\n   13. Patients must not have any unstable angina, or myocardial infarction within the last 6 months, or symptoms consistent with NYHA CHF classification III or IV\n   14. Participants with receipt of live vaccine within 28 days prior to registration.\n   15. Participants with history of autologous stem cell transplant within the last 60 days or allogeneic stem cell transplant within the last 90 days or CAR T-cell therapy within the last 180days.\n   16. Participants with a history of severe immediate hypersensitivity reaction to any of the agents used in the study\n   17. Participants with any other illness that in the opinion of the investigator, would exclude the patient from participating in this study.",{"count":365,"type":21},27,[24,25],"This is a single-center, nonrandomized, open-label dose-escalation study followed by dose-expansion of CD19- CD34t metabolically programmed CAR T-cell therapy in adult patients with relapsed or refractory CD19 B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL)\u002Fsmall lymphocytic lymphoma (SLL).",[149,369],"Chronic Lymphocytic Leukemia",[371,372,373,343,151,374],"NHL","CLL","SLL","CD34","2026-03-25",{"date":377,"type":37},"2026-03-27",{"date":379,"type":37},"2023-11-06",{"date":381,"type":21},"2026-12-30",{"name":383,"class":163},"Medical University of South Carolina",{"id":385,"slug":4,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":22,"phases":392,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":117},"100472496","NCT05432635","Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) Following Stem Cell Transplantation for the Treatment of Intermediate or High Grade B-cell Non-Hodgkin Lymphoma","Pilot\u002FFeasibility Study of CMV-Specific CD19-CAR T Cells Plus CMV-MVA Triplex Following Autologous Hematopoietic Stem Cell Transplantation for Patients With Intermediate or High Grade B-Lineage Non-Hodgkin Lymphoma (B-NHL)","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies.\n\n  * If unavailable, exceptions may be granted with study PI approval\n* Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter\u002Ftranslator to proceed with screening and leukapheresis, while the request for a translated full consent is processed\n* Age \\>= 18 years\n* Karnofsky performance status (KPS) \\>= 70\n* Life expectancy \\>= 16 weeks at the time of enrollment\n* Patients with an indication to be considered for HSCT, who are diagnosed with intermediate or high-grade B cell NHL (e.g., diffuse large B-cell lymphoma \\[DLBCL\\], mantle cell lymphoma \\[MCL\\], or transformed NHL) in first relapse after achieving complete remission (CR) or did not achieve CR after a first line therapy\n\n  * Note: COH pathology review should confirm that research participant's diagnostic material is consistent with history of intermediate or high-grade CD19+ malignancy\n* No known contraindications to myeloablative HSCT, leukapheresis, steroids or tocilizumab, smallpox vaccine and any other modified vaccinia Ankara (MVA)-based vaccines\n* Patient must be CMV seropositive\n* Total serum bilirubin =\\\u003C 2.0 mg\u002FdL\n* Participants with Gilbert syndrome may be included if their total bilirubin is =\\\u003C 3.0\n* Aspartate aminotransferase (AST) \\\u003C 2.5 x upper limits of normal (ULN)\n* Alanine aminotransferase (ALT) \\\u003C 2.5 x ULN\n* Serum creatinine =\\\u003C 2.5 x ULN or estimated creatinine clearance of \\>= 40 mL\u002Fmin per the Cockcroft-Gault formula, and the participant is not on hemodialysis\n* Absolute neutrophil count \\>= 1000\u002FuL (Transfusions and growth factors must not be used to meet this requirement at initial screening)\n* Hemoglobin (Hb) \\>= 8 g\u002Fdl (Transfusions and growth factors must not be used to meet this requirement at initial screening)\n* Platelet count \\>= 50,000\u002FuL (\\>= 30,000\u002FuL if bone marrow plasma cells are =\\> 50 percent of cellularity) (Transfusions and growth factors must not be used to meet this requirement at initial screening)\n* Left ventricular ejection fraction \\>= 45 percent within 8 weeks before enrollment\n* Oxygen (O2) saturation \\> 92% without requiring supplemental oxygen\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Prior autologous\u002Fallogeneic stem cell transplant\n* Growth factors within 14 days of enrollment\n* Platelet transfusions within 7 days of enrollment\n* Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled or topical steroids in standard doses is not exclusionary. Physiologic replacement of steroids (prednisone =\\\u003C 5 mg \u002Fday, or equivalent doses of other corticosteroids) is allowed\n* Patients with active autoimmune disease requiring systemic immune suppressive therapy are not allowed\n* Participants may not be receiving any other investigational agents or concurrent biological therapy, chemotherapy, or radiation therapy\n* Any standard contraindications to myeloablative HSCT per standard of care practices at COH\n* Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening\n* Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system (CNS), including seizure disorder, any measurable masses of CNS, or any other active CNS disease. Note: Research participants with a history of CNS disease that has been effectively treated to complete remission (\\\u003C 5 white blood cells \\[WBC\\] \u002F mm\\^3 and no blasts in cerebrospinal fluid \\[CSF\\]) will be eligible\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents or cetuximab\n* Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia\n* History of stroke or intracranial hemorrhage within 6 months prior to screening\n* History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for \\>= 3 years.\n* Clinically significant uncontrolled illness\n* Active infection requiring antibiotics\n* Immunodeficiency virus (human immunodeficiency virus \\[HIV\\]) positive\n* Active viral hepatitis\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures\n* Procedures (including compliance issues related to feasibility\u002Flogistics). Prospective participants who, in the opinion of the investigator, may not be able to comply with all study\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":391,"type":21},15,[24],"This phase I trial studies the safety and side effects of cytomegalovirus (CMV) specific CD19-chimeric antigen receptor (CAR) T-cells along with the CMV-modified vaccinia Ankara (MVA) triplex vaccine following a stem cell transplant in treating patients with high grade B-cell non-Hodgkin lymphoma. CAR T-cells are a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion. Vaccines such as CMV-MVA triplex are made from gene-modified viruses and may help the body build an effective immune response to kill cancer cells. Giving CMV-specific CD19-CAR T-cells plus the CMV-MVA triplex vaccine following a stem cell transplant may help prevent the cancer from coming back.",[108,395,396,397,398,399,400,401],"Diffuse Large B-Cell Lymphoma","Mantle Cell Lymphoma","Recurrent B-Cell Non-Hodgkin Lymphoma","Recurrent Diffuse Large B-Cell Lymphoma","Recurrent Mantle Cell Lymphoma","Recurrent Transformed Non-Hodgkin Lymphoma","Transformed Non-Hodgkin Lymphoma","2026-02-20",{"date":404,"type":37},"2026-02-23",{"date":406,"type":37},"2023-08-01",{"date":408,"type":21},"2028-12-30",{"name":410,"class":163},"City of Hope Medical Center",{"id":412,"slug":4,"hasResults":11,"nctId":413,"briefTitle":414,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":417,"enrollmentInfo":418,"targetDuration":4,"studyType":22,"phases":420,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":432},"100515429","NCT05991388","A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma","Glo-BNHL","Inclusion criteria applicable to all treatment arms:\n\n* Histologically proven mature B-NHL (Diffuse Large B-Cell Lymphoma (DLBCL), Burkitt Lymphoma\u002FLeukaemia or atypical Burkitt\u002FBurkitt-like lymphoma, primary mediastinal large B-cell lymphoma (PMLBL), and mature B-NHL\u002FNot Otherwise Specified (NOS)) at initial diagnosis\n* Radiologically and\u002For histologically proven B-NHL in first relapse (only one prior line of therapy) or subsequent relapse (more than one prior line of therapy) or refractory(\\*) B-NHL. (Note: relapses following prior targeted therapy must have continuing target positivity, confirmed by an established method).\n* If relapse occurs more than two years after previous therapy, a biopsy must be performed\n* Evaluable disease as per the international paediatric non-Hodgkin Lymphoma response criteria, including:\n\n  * at least one bi-dimensionally measurable nodal lesion \\>1.5 cm in its longest dimension;\n  * or at least one bi-dimensionally measurable extra-nodal lesion \\>1.0 cm in its longest dimension on computerised tomography (CT) or Magnetic Resonance Imaging (MRI);\n  * or bone marrow involvement (≥25% involvement from bone marrow, if only site of disease. Any standard method of assessment is acceptable i.e. cytomorphology, flow cytometry and\u002For immunohistochemistry);\n  * or, dependent on treatment arm, evaluable Central Nervous System (CNS) only disease (evaluable by imaging or Cerebrospinal Fluid (CSF) analysis)(\\*\\*)\n* Age from birth to ≤25 years old at the time of trial entry\n* Performance status ≥50 using Karnofsky or Lansky performance scores\n* Life expectancy of ≥8 weeks\n* Adequate bone marrow function documented by:\n\n  * Platelet count ≥50x 10\\^9\u002FL (no platelet transfusion therapy within seven days prior to treatment) unless bone marrow involvement(\\*\\*\\*)\n  * Absolute neutrophil count (ANC) ≥0.75 x 10\\^9\u002FL (no granulocyte colony stimulating factor within 2 days prior to treatment) unless bone marrow involvement(\\*\\*\\*)\n* Adequate hepatic function documented by:\n\n  * Aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) ≤5 x upper limit of normal (ULN)\n  * Total bilirubin ≤1.5 X ULN \\*\\*\\*Patients with known Gilbert syndrome will be excluded if the total bilirubin value is \\>4 x ULN for the local general population\n* Documented negative pregnancy test for female patients of childbearing potential within seven days prior to trial entry\n* Patients of reproductive potential agrees to use effective contraception whilst on trial treatment and for 12 months following treatment discontinuation\n* Written informed consent given by patient and\u002For parents\u002Flegal representative\n\nInclusion criteria applicable to treatment arm I only:\n\n* Male patients of reproductive potential must agree not to donate sperm whilst on trial treatment and for 6 months following treatment discontinuation\n* Adequate renal function, creatinine clearance \\>45 ml\u002Fmin by measurement or estimation (if creatinine levels are normal for the patient's age, using the Cockroft-Gault Equation is sufficient)\n* For patients with bone marrow involvement(\\*\\*\\*) or splenic sequestration, adequate bone marrow function documented by:\n\n  * Platelet count ≥25 x 10\\^9\u002FL (no platelet transfusion therapy within three days prior to treatment)\n  * Haemoglobin level ≥7 g\u002FdL\n  * Absolute neutrophil count (ANC) ≥0.5 x 10\\^9\u002FL (no granulocyte colony stimulating factor within two days prior to treatment)\n* Patients who have received CAR T-cell therapy or other cellular therapies more than 28 days prior must demonstrate recovery from acute toxicities and have measurable disease\n\nInclusion criteria applicable to treatment arm II only:\n\n* Adequate renal function, by measured glomerular filtration rate (GFR) \\>60 ml\u002Fmin\u002F1.73m\\^2 (estimated GFR is not sufficient)\n* For patients with bone marrow involvement(\\*\\*\\*) or splenic sequestration, requirements for bone marrow function do not apply\n\n(\\*) Refractory disease\n\nThe following patients are considered to have refractory disease and can be included in this trial:\n\n* Patients with who do not achieve PR or CR with last therapy\n* Patients with partial response to last therapy (biopsy proven), with no evidence of progression\n\n(\\*\\*) CNS only disease Patients with CNS only disease may be eligible depending on the treatment arm. Please refer to the relevant treatment arm specific eligibility criteria.\n\n(\\*\\*\\*) Bone marrow involvement Patients who have ≥ 25% blasts in the bone marrow are considered to have bone marrow involvement. For these patients, requirements for bone marrow function are dependent on treatment arm. Please refer to the relevant treatment arm specific eligibility criteria.\n\nExclusion Criteria:\n\n* B-cell Acute Lymphoblastic Leukaemia (B-ALL)\u002FB-cell Lymphoblastic Lymphoma (B-LBL)\n* Patients within:\n\n  * 90 days after an allogenic HSCT procedure\n  * 45 days after an autologous HSCT procedure\n  * 28 days of experiencing graft versus host disease (GvHD) requiring systemic therapy, and\u002For immunosuppressive treatment\n  * 14 days of previous investigational treatment\n  * 28 days of receiving craniospinal radiation; or 14 days of any other radiation\n  * For patients who have received any CAR T-cell therapy or other cellular therapies, see treatment arm specific eligibility criteria\n* Patients who have ongoing acute toxicities from most recent lymphoma directed therapy\n* Patients with known DNA repair disorder or known primary immunodeficiency\n* Patients who are pregnant or breastfeeding (exclusively or partially)\n* Patients who cannot regularly be followed up in accordance with the protocol due to psychological, social, geographical or other issues\n* Patients for whom non-compliance with treatment or trial procedures is expected\n* Uncontrolled concomitant infection. Severe infection (such as sepsis, pneumonia, etc.) should be clinically controlled at the time of trial entry\n* Known HIV positivity\n* Hepatitis B carrier status, history of Hepatitis B Virus or positive serology. A patient is considered as a Hepatitis B Virus carrier or to have (had) Hepatitis B Virus infection in case of:\n\n  * Unimmunized and HBsAg and\u002For anti-HBs antibody and\u002For anti- HBc antibody positive,\n  * Immunized and HBsAg and\u002For anti-HBc antibody positive.\n* Live vaccine within 28 days prior to trial entry\n* Known history of hypersensitivity to any of the treatments or excipients\n\nExclusion criteria applicable to treatment arm I only:\n\n* Central Nervous System (CNS) only disease\n* Patients within 28 days of any CAR-T cell therapy or other cellular therapies\n* Left ventricular shortening fraction (LVSF) \\\u003C27% or left ventricular ejection fraction (LVEF) \\\u003C50%, as determined by ECHO or MUGA, any evidence of pericardial effusion (except trace or physiological) as determined by an ECHO, and any clinically significant arrhythmias\n* Known CD20 negative disease at initial diagnosis\n* Seizure within the last 12 months\n* Prior treatment with CD20 x CD3 bispecific therapy\n* Known hypersensitivity to both allopurinol and rasburicase\n\nExclusion criteria applicable to treatment arm II only:\n\n* Patients within 42 days of any CAR-T cell therapy or other cellular therapies\n* Clinically significant (Grade ≥2) third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)\n* Steroid treatment for more than a total of seven days in the 14 days prior to trial entry","25 Years",{"count":419,"type":21},210,[25,421],"PHASE3","The Glo-BNHL trial is trying to find better medicines for children and young people with B-cell non-Hodgkin Lymphoma (B-NHL) that does not go away (refractory B-NHL) or does but comes back again (relapsed B-NHL). B-NHL is a type of cancer that develops inside or outside of lymph nodes (glands) and organs such as the liver or spleen. Examples of B-NHL are Burkitt Lymphoma and Diffuse Large B Cell Lymphoma, which may be other names used to describe this type of cancer. It is very difficult to cure relapsed or refractory B-NHL. The medicines used now are very powerful with many side effects and only cure around 30 in every 100 children treated. It is very important that investigators quickly find better medicines for these children and young people.\n\nThe Glo-BNHL trial will include three groups of children and young people, each given a new medicine (either alone or with chemotherapy). The investigators are looking to make sure the new medicines are safe and that they work to treat the cancer. If the medicine in one group does not work for a child in the trial, then they may be able to join a different group to have another new medicine.\n\nExperts from around the world will carefully pick the medicines most likely to be helpful to be part of the trial. If one of the new medicines seems not to be working as well as hoped then the investigators will take it out of the trial as soon as possible. This will let other new medicines be added to the trial and tested. If a medicine does seem to be working well, then it will continue in the trial to make sure it really is the most useful medicine available.\n\nChildren from around the world will be invited to take part in the trial. The investigators will then check on them for at least two years after they finish the trial treatment to look for possible side effects of the new medicine.",[149],"2026-02-18",{"date":402,"type":37},{"date":427,"type":37},"2024-05-02",{"date":429,"type":21},"2033-05-01",{"name":431,"class":163},"University of Birmingham",11,{"id":434,"slug":4,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":22,"phases":440,"briefSummary":441,"conditions":442,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":117},"100530830","NCT06191887","B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells With Fludarabine and Cyclophosphamide Lymphodepletion for the Treatment of Relapsed or Refractory B-cell Hematologic Malignancies","Phase 1a\u002F1b Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells (MC10029) in Subjects With Relapsed or Refractory BAFFR-Expressing B-Cell Hematologic Malignancies","Inclusion Criteria:\n\n* PRE-REGISTRATION: Age ≥ 18 years\n* PRE-REGISTRATION: Confirmed diagnosis of 1 of the following relapsed or refractory B-cell hematologic malignancies: chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), or large B cell lymphoma (LBCL) including Richter's transformation from CLL\u002FSLL\n\n  * For CD19+ B cell malignancies; relapsed or refractory disease is defined by one of the following histopathology:\n\n    * Biopsy proven SLL or flow cytometry proven CLL; relapsed or refractory disease is defined as:\n    * Demonstration of progressive or stable disease by positron emission tomography\u002Fcomputed tomography (PET\u002FCT) or computed tomography (CT) criteria according to the international workshop on chronic lymphocytic leukemia (iwCLL) 2018 criteria\n    * Biopsy proven B-cell non-Hodgkin lymphoma (NHL) of any histopathology (including Richter Transformation of CLL); relapsed or refractory disease is defined as:\n    * Demonstration of progressive or stable disease by PET\u002FCT or CT criteria as the best response to the most recent chemotherapy regimen according to the revised Lugano Response Criteria for Malignant Lymphoma\n* PRE-REGISTRATION: Disease Specific prior lines of therapies below:\n\n  * For CLL\u002FSLL, patients must have received ≥ two prior lines of therapy, and\u002For ≥ 6 months of second line prior BTK inhibition (e.g. ibrutinib or other such as acalabrutinib or zanubrutinib) and must have failed to respond to venetoclax or be intolerant. Exception: Patients in stable disease (SD) or partial response (PR) with a known ibrutinib resistance mutation (BTK or phospholipase Cγ2) may be included even if on ibrutinib therapy for less than 6 months\n\n    * These patients may or may not have received prior antibody directed against cluster of differentiation 20 (CD20).\n  * For Follicular Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20.\n\n    * NOTE: Prior cluster of differentiation 19 (CD19) directed chimeric antigen receptor T-cell therapy (CART) must have a 100-day washout period.\n  * For Mantle Cell Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20, and a BTK inhibitor.\n\n    * NOTE: Prior CD19 directed CART must have a 100-day washout period.\n  * For Marginal Zone Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20.\n\n    * NOTE: Prior CD19 directed CART must have a 100-day washout period.\n  * For Large B cell Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20. Prior exposure to CD19 directed CART will be allowed at the discretion of the Principal Investigator.\n\n    * NOTE: Prior failed CD19 directed CART must have a 100-day washout period\n  * For Richter's Transformation, patients must have received ≥two prior lines of therapy, including an antibody directed against CD20.\n  * 100-day washout period starts from the date of the last prior CAR-T infusion.\n* PRE-REGISTRATION: Measurable disease\n* REGISTRATION: Positive BAFFR test\n* REGISTRATION: Measurable disease\n* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2\n* REGISTRATION: Hemoglobin ≥ 9.0 g\u002FdL (unless due to documented marrow involvement with disease) obtained ≤14 days prior to registration\n* REGISTRATION: Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (unless due to documented marrow involvement with disease) obtained ≤14 days prior to registration\n* REGISTRATION: Platelet count ≥100,000\u002Fmm\\^3 (unless due to documented marrow involvement with disease) obtained ≤ 14 days prior to registration\n* REGISTRATION: Total bilirubin ≤ 1.5 x upper limits of normal (ULN) (Subjects with Gilbert's Syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) obtained ≤ 14 days prior to registration\n* REGISTRATION: Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) obtained ≤ 14 days prior to registration\n* REGISTRATION: Prothrombin time (PT)\u002Finternational normalized ratio (INR) \u002Factivated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy obtained ≤ 14 days prior to registration\n\n  * Patients on a stable, maintenance regimen of anticoagulant therapy for ≥ 30 days prior to registration may have PT\u002FINR measurements \\> 1.5 X ULN if, in the judgment of the investigator, the patient is suitable for the study\n* REGISTRATION: Calculated creatinine clearance ≥45 ml\u002Fmin using the Cockcroft-Gault formula obtained ≤ 14 days prior to registration\n* REGISTRATION: Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* REGISTRATION: Provide written informed consent understand and comply with protocol-required study procedures\n* REGISTARTION: Patients must have an ejection fraction (EF) of ≥ 45%\n* REGISTRATION: Patients must have pulse ox measurements of \\> 92% on room air\n* REGISTRATION: Willingness to provide mandatory blood specimens for correlative research\n* REGISTRATION: Willing to return to enrolling institution for study follow-up\n\nExclusion Criteria:\n\n* PRE-REGISTRATION: Prior solid organ transplantation\n* PRE-REGISTRATION: Unstable angina, clinically significant arrhythmia, or myocardial infarction ≤ 6 months of prior to pre-registration, or grade 3 or higher pericardial effusion at the time of pre-registration\n* PRE-REGISTRATION: Prior anti-BAFF-R therapies\n* PRE-REGISTRATION: Known contraindication to lymphodepleting (LD) chemotherapy\n* PRE-REGISTRATION: Use of systemic antitumor therapy or investigational agent ≤ 14 days, prior to pre-registration\n* PRE-REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the BAFF-R\n* PRE-REGISTRATION: Autologous HCT ≤ 60 days prior to pre-registration\n* PRE-REGISTRATION: Uncontrolled intercurrent non-cardiac illness including, but not limited to:\n\n  * Previous or concurrent malignancy\n  * Ongoing or active infection\n  * Psychiatric illness\u002Fsocial situations\n  * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy \\* Persons of childbearing potential who are pregnant or breastfeeding\n  * Life Expectancy of \\\u003C 6 weeks\n  * Persons requiring systemic corticosteroids (\\>10 mg prednisone or equivalent per day) and\u002For other immunosuppressive therapy. Patients are allowed to use topical corticosteroids\n  * Any other conditions that would limit compliance with study requirements\n* PRE-REGISTRATION: Detectable malignant cells from cerebrospinal fluid (CSF) or magnetic resonance imaging (MRI) indicating brain metastases during screening, or a history of central nervous system (CNS) involvement by malignancy (CSF or imaging) with still active disease. Note: Patients with a history of CNS involvement resolving after treatment and without active disease will be considered eligible if other inclusion criteria are met\n* PRE-REGISTRATION: History of a seizure disorder, major cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n* PRE-REGISTRATION: Radiation therapy ≤ 14 days prior to pre-registration\n* PRE-REGISTRATION: Prior allogeneic hematopoietic stem cell transplant (HCT) in ≤ 6 months prior to pre-registration; patients with active graft versus host disease (GVHD) will not be eligible regardless of duration from prior allogeneic HCT\n* PRE-REGISTRATION: Human immunodeficiency virus (HIV) positive patients\n* PRE-REGISTRATION: Subjects with New York Health Association (NYHA) class III or greater heart failure\n* REGISTRATION: Eligible for auto-HCT based on investigator judgement\n* REGISTRATION: Presence of active bacterial, viral, or fungal infection that is uncontrolled, based on investigator judgment\n* REGISTRATION: Patients with active hepatitis B or hepatitis C infections are excluded from the study. Patients who are documented to be HIV positive or proven HIV infection from testing are ineligible for the study. Infectious disease testing (HIV-1, HIV-2, hepatitis C virus (HCV) antibody and polymerase chain reaction (PCR), hepatitis B virus (HBV) surface antigen, HBV surface antibody, HBV core antibody) performed ≤ 45 days prior to registration may be considered for subject eligibility\n* REGISTRATION: Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥ 5 years prior to registration\n* REGISTRATION: Persons of childbearing potential who are pregnant or breastfeeding\n* REGISTRATION: Life expectancy of \\\u003C 6 weeks",{"count":365,"type":21},[24],"This phase I trial tests safety, side effects and best dose of B-cell activating factor receptor (BAFFR)-based chimeric antigen receptor T-cells, with fludarabine and cyclophosphamide lymphodepletion, for the treatment of patients with B-cell hematologic malignancies that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). BAFFR-based chimeric antigen receptor T-cells is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving chemotherapy, such as fludarabine and cyclophosphamide, helps ill cancer cells in the body and helps prepare the body to receive the BAFFR based chimeric antigen receptor T-cells. Giving BAFFR based chimeric antigen receptor T-cells with fludarabine and cyclophosphamide for lymphodepletion may work better for the treatment of patients with relapsed or refractory B-cell hematologic malignancies.",[108,443,398,444,399,445,446,447,448,449,450,451,452,453,454],"Recurrent Chronic Lymphocytic Leukemia","Recurrent Follicular Lymphoma","Recurrent Marginal Zone Lymphoma","Recurrent Small Lymphocytic Lymphoma","Recurrent Transformed Chronic Lymphocytic Leukemia","Refractory Chronic Lymphocytic Leukemia","Refractory Diffuse Large B-Cell Lymphoma","Refractory Follicular Lymphoma","Refractory Mantle Cell Lymphoma","Refractory Marginal Zone Lymphoma","Refractory Small Lymphocytic Lymphoma","Refractory Transformed Chronic Lymphocytic Leukemia","2026-02-11",{"date":457,"type":37},"2026-02-13",{"date":459,"type":37},"2024-03-18",{"date":461,"type":21},"2040-12-31",{"name":234,"class":163},{"id":464,"slug":4,"hasResults":11,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":22,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":117},"100544191","NCT06365671","CAR-T Following ASCT for Relapsed\u002FRefractory B-Cell Non-Hodgkin's Lymphoma (R\u002FR B-NHL) With High-Risk Prognostic Factors","A Single-Arm Clinical Study of CD19 CAR-T Following ASCT for Relapsed\u002FRefractory B-Cell Non-Hodgkin's Lymphoma (R\u002FR B-NHL) With High-Risk Prognostic Factors","Inclusion Criteria:\n\n1. Histologically confirmed B-cell non-Hodgkin's lymphoma including the following types\n\n   * diffuse large B-cell lymphoma\n   * high-grade B-cell lymphoma with or without MYC and BLC2 and\u002For BCL6 rearrangement\n   * transformed lymphoma\n   * primary mediastinal large B-cell lymphoma\n   * follicular lymphoma (FL)\n2. Relapsed or refractory diseases fulfilling one of the following criteria (individuals must have received anti-CD20 monoclonal antibody and anthracycline-containing chemotherapy regimen)\n\n   * Primary refractory disease, defined as disease progression after first-line immunochemotherapy or disease progression within 6 weeks of the end of the last chemotherapy\n   * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n   * Partial response (PR) as best response after at least 6 cycles of first-line therapy (biopsy-proven residual disease is needed for individuals with Deauville score of 4)\n   * PR as best response after at least 2 cycles of second-line therapy\n   * Disease relapse ≤12 months after the completion of first-line immunochemotherapy\n   * Relapsed or refractory disease after ≥2 lines of chemotherapy\n3. Presence of at least one of the following high-risk prognostic factors: (1) extranodal involvement; (2) maximum diameter of the bulky mass ≥5 cm; (3) TP53 gene alterations\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n5. Eligible for HDCT\u002FASCT based on the investigator's assessment and are scheduled to undergo an ASCT sequential CAR-T treatment regimen\n6. Adequate renal and hepatic function defined as:\n\n   * Serum alanine aminotransferase (ALT\u002FAST) ≤ 3 upper limit of normal (ULN)\n   * Total bilirubin ≤1.5 mg\u002FdL(\\\u003C3 times ULN in patients with Gilbert's syndrome, cholestasis due to hepatoportal compression adenopathy, biliary obstruction in patients with liver involvement or lymphoma)\n   * Serum creatinine ≤1.5 ULN, or creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL\u002Fmin\n7. Cardiac ejection fraction ≥ 40%\n8. Baseline oxygen saturation \\> 95% on room air\n9. Life expectancy ≥3 months\n\nExclusion Criteria:\n\n1. History of autologous or allogeneic stem cell transplantation\n2. Active HBV or HCV infection, defined as HBV-DNA or HCV-DNA levels above the normal upper limit, with or without abnormal liver function. Individuals with positive HBsAg or HBcAb should receive antiviral prophylaxis for at least 12 months after CAR-T cells infusion.\n3. Presence of uncontrolled infection, cardio-cerebrovascular disease，coagulopathy, or connective tissue disease.\n4. History of HIV infection\n5. Prior chimeric antigen receptor cellular immunotherapy targeting CD19\n6. Pregnant or lactating patients",{"count":470,"type":21},16,[25],"Clinical trial for the safety and efficacy of CD19 CAR-T following autologous hematopoietic stem cell transplantation (ASCT) for Relapsed\u002FRefractory B-Cell Non-Hodgkin's Lymphoma (R\u002FR B-NHL) with High-Risk Prognostic Factors",[149],"2026-01-03",{"date":476,"type":37},"2026-01-06",{"date":478,"type":37},"2024-04-16",{"date":480,"type":21},"2027-04",{"name":300,"class":163},{"id":483,"slug":4,"hasResults":11,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":22,"phases":490,"briefSummary":491,"conditions":492,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":470},"100546249","NCT06392477","A Study to Evaluate the Safety and Activity of SAR448501\u002FDR-0201 in Patients With Relapsed\u002F Refractory B-Cell Non-Hodgkin Lymphoma","A Multicenter, Multiple Expansion Cohort Phase 1 Study Evaluating the Safety and Activity of SAR448501\u002FDR-0201 as Multiple Ascending Doses in Patients With Relapsed\u002FRefractory B Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Participants with R\u002FR B-NHL which has failed at least 2 prior lines available life-prolonging standard therapy and without treatment options that are recognized to offer clinical benefit.\n* Adequate marrow reserve, renal function, and hepatic function.\n* Measurable disease defined as ≥ 1 bi-dimensionally measurable nodal lesion of \\> 1.5 cm in the longest dimension for participants with fluorodeoxyglucose (FDG)-avid disease for subtypes with nodular disease or at least one bi-dimensionally measurable extranodal lesion, defined as \\> 1.0 cm in its longest dimension.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Life expectancy of ≥ 12 weeks.\n* Use of a highly effective contraceptive measure for all males and all females of childbearing potential during study through 180 days post last dose; Females of childbearing potential need to have a negative serum pregnancy test within 7 days prior to first dose.\n* Tumor tissue block or 3 to 5 unstained slides from lymph node or other relevant biopsy collected in the past 12 months. Participants must be willing to provide a baseline and at least 1 on-treatment biopsy, unless not safely accessible.\n* Participants who have received prior CAR-T therapy must be \\>60 days post CAR-T at day of first dosing.\n\nExclusion Criteria:\n\n* Burkitt's or Burkitt's like lymphoma or lymphoplastic lymphoma.\n* Current history of central nervous system (CNS) involvement by malignancy.\n* Prior allogeneic stem cell transplantation except for those with follicular lymphoma (FL) and mantle cell lymphoma (MCL), who are excluded if transplant occurred less than 100 days prior to dosing or if they exhibit grade \\> 1 graft versus host disease.\n* Prior solid organ transplantation.\n* Autologous stem cell transplantation ≤ 100 days prior to dosing.\n* History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematous, rheumatoid arthritis, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjorgen's syndrome, Guillain-Barre-syndrome, multiple sclerosis vasculitis, or glomerulonephritis (participants with a remote history of, or well-controlled autoimmune disease, may be eligible).\n* Major surgery in the last 28 days prior to dosing.\n* Evidence of significant, uncontrolled concomitant disease that could affect compliance with study.\n* Current or past history of CNS disease (participants with remote history of non-lymphoma CNS disease and with no residual neurologic deficits may be eligible to enroll).\n* QT interval corrected by Fridericia's formula (QTcF) \\> 480 msec.\n* Significant cardiovascular disease.\n* Received any anticancer systemic therapy within 4 weeks prior to first drug administration or 5 half-lives of the drug, whatever is shorter. Treatment with corticosteroid ≤ 25 mg\u002Fday prednisone or equivalent is allowed. Inhaled and topical steroids are allowed.\n* Known infection with HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV).\n* Active infection at baseline requiring systemic treatment with antimicrobial, antifungal, or antiviral agents in the 2 weeks prior to dosing.\n* Administration of a live, attenuated vaccine within 4 weeks prior to first drug administration or anticipation that such vaccine administration would be necessary during the course of the study.\n* Another invasive malignancy in the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin, asymptomatic prostate cancer requiring only hormonal therapy and with normal prostate-specific antigen for \\> 1 year, and tumors deemed by the investigator to be of low likelihood for recurrence).\n* Prothrombin time\u002Finternational normalized ratio (INR) and activated partial thromboplastin time or partial thromboplastin time (aPTT\u002FPTT) \\> 1.3 × ULN or outside the therapeutic range of the local laboratory if receiving therapeutic anticoagulation that would affect the prothrombin time\u002FINR, participants with a history of a hypercoagulation event within 6 months, or participants who have known hypercoagulation risk factors will be excluded.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":489,"type":21},96,[24],"This is an open-label, multiple ascending dose (MAD), phase 1 study in adult patients with relapsed or refractory (R\u002FR) B cell non-Hodgkin lymphoma (B-NHL). The purpose of the study is to identify possible optimal biological dosage(s) by assessing safety, tolerability, pharmacokinetics (PK), pharmacodynamics, clinical activity and immunogenicity of SAR448501\u002FDR-0201.\n\nThe study duration per participant will be approximately 3 years, including a screening period of up to 28 days, a treatment period of 52 weeks, a safety follow-up period of approximately 28 days and a long-term follow-up period of every 3 months until withdrawal of consent, participant death or study closure, whichever is sooner.",[149],"2025-12-16",{"date":495,"type":37},"2025-12-23",{"date":497,"type":37},"2024-07-08",{"date":499,"type":21},"2028-02-11",{"name":501,"class":44},"Sanofi",{"id":503,"slug":4,"hasResults":11,"nctId":504,"briefTitle":505,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":22,"phases":510,"briefSummary":512,"conditions":513,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":526,"locationsCount":528},"100555183","NCT06508775","Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies","LONGSAFE","Inclusion Criteria:\n\n* Patient underwent treatment with a Miltenyi CAR T cell therapy in one of the parent trials at least 12 months prior to enrollment in long-term follow-up.\n* Patient has provided informed consent prior to enrollment.\n\nExclusion Criteria:\n\n* No exclusion criteria",{"count":509,"type":21},40,[511],"NA","The goal of this Long-Term Follow-Up Trial is to assess long-term safety and efficacy of Miltenyi CAR T treatment.",[514,149,515,516,517,518,519],"Melanoma Stage III","Pediatric ALL","Childhood Non-Hodgkin Lymphoma","Acute Lymphatic Leukemia","Chronic Lymphatic Leukemia","Melanoma Stage IV","2025-11-20",{"date":522,"type":37},"2025-11-26",{"date":524,"type":37},"2024-05-05",{"date":461,"type":21},{"name":527,"class":44},"Miltenyi Biomedicine GmbH",7,{"id":530,"slug":4,"hasResults":11,"nctId":531,"briefTitle":532,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":534,"enrollmentInfo":535,"targetDuration":4,"studyType":22,"phases":536,"briefSummary":537,"conditions":538,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":117},"100570439","NCT06707259","Clinical Study of Cord Blood-derived IL-10\u002FIL-15 CD19-CAR NK in the Treatment of Refractory\u002FRelapsed B-cell NHL","Inclusion Criteria:\n\n1. Volunteer to participate in this study and sign an informed consent form;\n2. Age 18-75 years old, no gender limit;\n3. Histologically diagnosed as diffuse large B-cell lymphoma (DLBCL), transforming follicular lymphoma (TFL), primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL) and other inert B-cells NHL conversion type:(1) Refractory or relapsed DLBCL refers to the failure to achieve complete remission after 2-line treatment; disease progression during any treatment, or disease stable time equal to or less than 6 months; or disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation ； (2) Refractory or relapsed MCL must be resistant to or intolerable to BTK inhibitors; (3) Refractory or relapsed indolent B-cell NHL is the failure or recurrence of third-line treatment; (4) Previous treatment must include CD20 monoclonal antibody treatment (unless the subject is CD20 negative) and anthracyclines;\n4. At least one measurable lesion with the longest diameter ≥ 1.5 cm exists;\n5. The expected survival period is ≥12 weeks;\n6. The puncture section of the tumor tissue was positive for CD19 expression; 7, ECOG score 0-2 points;\n7. Sufficient organ function reserve: (1) Alanine aminotransferase, aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value); (2) Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL\u002Fmin; (3) Serum total bilirubin and alkaline phosphatase ≤1.5× UNL; （4）Glomerular filtration rate\\>50Ml\u002Fmin Cardiac ejection fraction (EF) ≥50%; (5) Under natural indoor air environment, basic oxygen saturation\\>92% .\n8. Allow a previous stem cell transplantation.\n9. The approved anti-B-cell lymphoma treatments, such as systemic chemotherapy, systemic radiotherapy, and immunotherapy, have been completed for at least 3 weeks before the study medication;\n10. Allow patients who have previously received CAR-T cell therapy and have failed or relapsed after 3 months of evaluation;\n11. Female subjects of childbearing age must have a negative pregnancy test and agree to take effective contraceptive measures during the trial.\n12. Two tests for the new coronavirus were negative.\n\nExclusion Criteria:\n\n1. Those who have a history of allergies to any of the ingredients in cell products;\n2. History of other tumors;\n3. Previously presented with II-IV degree (Glucksberg criteria) acute GvHD or extensive chronic GvHD; or are receiving anti-GvHD treatment;\n4. Have received gene therapy in the past 3 months;\n5. Active infections that require treatment (except for simple urinary tract infections and bacterial pharyngitis), but preventive antibiotics, antiviral and antifungal infection treatments are allowed;\n6. Hepatitis B (HBsAg positive, but HBV-DNA \\\u003C103 is not an exclusion criterion) or hepatitis C virus infection (including virus carriers), syphilis and other subjects with acquired and congenital immunodeficiency diseases, including but not limited to people living with HIV;\n7. According to the New York Heart Association's Heart Function Classification Standard, it is classified as Grade III or Grade IV impaired subjects;\n8. Those who have received anti-tumor therapy in the early stage but the toxic reaction has not recovered (the CTCAE 5.0 toxic reaction has not recovered to ≤1, except for fatigue, anorexia, and hair loss);\n9. Subjects with a history of epilepsy or other central nervous system diseases; 10. Enhanced CT or MRI of the head showed evidence of central nervous system lymphoma;\n\n11\\. Have any other drugs that target CD19; 12. Women who are breastfeeding and unwilling to stop breastfeeding; 13. Any other situation that the investigator believes may increase the subject's risk or interfere with the test results.","75 Years",{"count":145,"type":21},[24],"To study the safety and effectiveness of cord blood-derived IL-10\u002FIL-15 CD19-CAR NK in patients with B-cell non-Hodgkin's lymphoma",[149],"2025-11-17",{"date":520,"type":37},{"date":542,"type":37},"2024-12-01",{"date":544,"type":21},"2027-12-01",{"name":546,"class":163},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":548,"slug":4,"hasResults":11,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":552,"eligibilityCriteria":553,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":534,"enrollmentInfo":554,"targetDuration":4,"studyType":22,"phases":555,"briefSummary":556,"conditions":557,"keywords":558,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":564,"locationsCount":117},"100597067","NCT07053670","A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma ( CT1190B-CG11001 )","A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell Therapy, in Patients With Relapsed\u002FRefractory B-Cell Non-Hodgkin Lymphoma","CT1190B","Inclusion Criteria:\n\n1. Participants must voluntarily sign the informed consent form (ICF) and must be willing and be able to adhere to the study visit schedule and other protocol requirements and agree to be in long term follow-up (LTFU) for up to 15 years as mandated by the regulatory guidelines.\n2. 18-75 years old;\n3. Histologically or cytologically confirmed B-NHL, according the 5th edition of the WHO classification of haematolymphoid tumours, including:\n\n1\\) Cohort A1: Large B-cell lymphoma, including diffuse large B-cell lymphoma not other specified (DLBCL, NOS), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, transformed follicular large B-cell lymphoma (FLBL)\u002FGrade 3b follicular lymphoma ( FL) ; 2) Cohort A2: Mantle cell lymphoma (MCL); 3) Cohort B1: Grade 1 \\~ 3a FL; 4) Cohort B2: chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL) according to iwCLL2018 diagnose criteria , with the exception of participants who are currently transformed into Richter 's syndrome; 5) Cohort C:Primary central nervous system lymphoma （PCNSL). 4. Previous treatment requirement:\n\n1. Cohort A1: Previously received at least 2 lines of systemic therapy, including anti-CD20 drugs (unless the investigator had determined that the tumor is\u002Fis CD20 negative) and anthracycline containing regimens, anti-CD20 drugs maintenance alone will not be counted as 1 line of treatment; for participants with transformed FL (FLBL), any treatment administered prior to transformation will not be counted as a prior line.\n2. Cohort A2: at least 2 prior lines of systemic therapy, including anthracycline or bendamustine-containing chemotherapy, anti-CD20 drugs ( unless the investigator had determined that the tumor is\u002Fis CD20 negative) and a BTK inhibitor; and CD20 monoclonal antibody alone will not be count as 1 line of treatment;\n3. Cohort B1: previously received at least 2 lines of systemic therapy, including anti-CD20 drugs ( unless the investigator had determined that the tumor is\u002Fis CD20 negative) and anthracycline-containing chemotherapy regimens, and CD20 monoclonal antibody alone will not be counted as 1 line of treatment;\n4. Cohort B2: at least 2 prior lines of therapy, including immunotherapy or chemotherapy and a BTK inhibitor, or BTK inhibitor who are not suitable for immunotherapy or chemotherapy.\n5. Cohort C:at least 1 line of therapy, including MTX based chemotherapy. 5. Intolerance to last treatment, or have progressed on or after the last treatment and currently require therapy.\n\n6\\. At least one of the following:\n\n1\\) CT or MRI testing: Intranodal lesions \\> 1.5 cm in long diameter, or Extranodal lesions \\> 1.0 cm in long diameter; 2)PET-CT testing: \\[18F\\] fluorodeoxyglucose (FDG) positron emission tomography (PET) positive lesion per Lugano criteria at screening (Deauville score 4 or 5); 3) CLL participants requiring treatment according to iwCLL criteria (refer to Appendix 4); 7. Expected survival \\> 12 weeks; 8. Eastern Cooperative Oncology Group (ECOG) score 0-1,PCNSL ECOG score: 0\\~3; 9. Participants should meet the following test results\n\n1. CBC: # platelet (PLT) ≥ 75 × 10 9\u002FL (for participants with bone marrow or peripheral blood involvement: PLT ≥ 50 × 10 9\u002FL), #hemoglobin (Hb) ≥ 80 g\u002FL (for participants with bone marrow or peripheral blood involvement: Hb ≥ 60 g\u002FL);\n2. Endogenous creatinine clearance ≥ 30 mL\u002Fmin (using the Cockcroft -Gault formula);\n3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN and total bilirubin ≤ 1.5 × ULN ; if there is liver involvement: AST and ALT ≤ 5 × ULN and total bilirubin ≤ 3.0 × ULN ;\n4. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n\n10\\. Female participants of childbearing potential must have a negative pregnancy test at screening and prior to receiving preconditioning therapy and are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment and are absolutely prohibited from donating eggs for 1 year after receiving study treatment infusion during the study; male participants are willing to use a highly effective and reliable method of contraception for 1 year after receiving study treatment if they are sexually active with a female of childbearing potential. Sperm donation is absolutely prohibited for 1 year after receiving study treatment infusions during the study for all male participants.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Has HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA above the detection limit), or active hepatitis C virus infection (HCV antibody and HCV-DNA positive);\n3. Has any current uncontrolled active infection, including but not limited to participants with active tuberculosis (investigator 's judgment);\n4. Participants' toxicities caused by previous treatment did not recover to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade 1, except alopecia and other events that are judged tolerable by the investigator;\n5. Autologous stem cell transplantation within 12 weeks prior to signing informed consent;\n6. Prior therapy targeting CD19 (unless CD19 or CD20 target remains positive) ;\n7. Has received treatment for the disease within 14 days or 5 half-lives (Based on a shorter period of time ) before FC, including but not limited to cytotoxic therapy, monoclonal antibodies or ADCs, targeted therapy, radiotherapy, epigenetic therapy, or investigational agents, or invasive investigational medical devices within 14 days before informed consent. If the radiation field covers ≤ 5% of the bone marrow reserve, the participant is eligible regardless of the end date of radiotherapy;\n8. Systemic glucocorticoids equivalent to \\> 15 mg\u002Fday prednisone within 7 days prior to informed consent, with the exception of topical glucocorticoids;\n9. Vaccination with live attenuated vaccines, inactivate vaccines or RNA vaccines within 4 weeks prior to informed consent;\n10. Participants who are allergic or intolerant to preconditioning drugs, tocilizumab, or allergic to the components (DMSO) in CT1190B cell infusion preparation; or have other previous history of severe allergy such as anaphylactic shock;\n11. Participants with any of the following cardiac conditions within 6 months prior to screening:\n\n1\\) New York Heart Association (NYHA) Class III or IV heart failure; 2) Myocardial infarction, coronary artery bypass graft surgery, or unstable angina within 6 months before screening; 3) History of clinically significant uncontrolled arrhythmia, e.g., ventricular arrhythmia; 4) History of severe non-ischemic cardiomyopathy; 5) Left ventricular ejection fraction (LVEF) \\\u003C 45% as assessed by echocardiogram or multimodal acquisition (MUGA) scan; 6) Other cardiac diseases that, in the opinion of the investigator, may jeopardize the participant 's well-being due to participation in this clinical study; 12. Oxygen saturation \\\u003C 92%, or suffering from other serious lung diseases, which may endanger the participant 's life as judged by the investigator; 13. Presence of a second primary malignancy requiring treatment or not in complete remission within the past 2 years, except for the following successfully treated tumors with low malignancy such as non-metastatic basal cell or squamous cell skin cancer, non-metastatic prostate cancer, breast or cervical carcinoma in situ, non-muscle-invasive bladder cancer, or thyroid cancer; 14. Major surgery within 2 weeks before informed consent or planned during the study period or within 4 weeks after giving study treatment (excluding local anesthesia such as cataract); 15. Participants are unable or unwilling to comply with the requirements of the study protocol or are otherwise unsuitable for participating in this clinical study in the investigator 's assessment,;",{"count":365,"type":21},[24],"A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell therapy, in Patients with Relapsed\u002FRefractory B-Cell Non-Hodgkin's Lymphoma.",[108],[552],"2025-11-13",{"date":539,"type":37},{"date":562,"type":37},"2025-07-09",{"date":381,"type":21},{"name":565,"class":163},"Tongji Hospital",{"id":567,"slug":4,"hasResults":11,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":22,"phases":573,"briefSummary":574,"conditions":575,"keywords":582,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":136},"100610273","NCT07225439","Rituximab (Rtx) + Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed\u002FRefractory (r\u002Fr) B-cell Non-Hodgkin Lymphoma (NHL)","Phase I Clinical Trial of Rituximab (Rtx) and Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed\u002FRefractory (r\u002Fr) B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of B-cell NHL (indolent and aggressive subtypes) including diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS), high grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL)\n* Participants must have measurable disease as defined by Lugano 2014 criteria for NHL or iwCLL 2018 criteria for CLL. For NHL, measurable disease is defined as ≥1 measurable lesion (nodal or extra nodal) ≥1.5 cm in longest diameter by CT or PET\u002FCT. For CLL, iwCLL criteria includes: presence of lymphocytosis (e.g., ALC ≥5 × 10⁹\u002FL), lymphadenopathy ≥1.5 cm, and\u002For disease-related cytopenias (anemia, thrombocytopenia).\n* Relapsed and\u002For refractory after two or more lines of systemic therapy, including prior CD19 and\u002For CD20 directed therapies\n* For participants who have received a prior CD19 or CD20 directed therapy, the presence of CD19 and\u002For CD20 expression (by flow cytometry and\u002For immunohistochemistry) must be demonstrated on a post-treatment relapse biopsy\n* ECOG Performance Status \\\u003C\u002F= 2\n* Preserved organ function as defined by: Total bilirubin \\\u003C\u002F= 1.5X upper limit of normal; AST\u002FALT \\\u003C\u002F= 2.5 X upper limit of normal; Calculated creatinine clearance \\>\u002F= 30mL\u002Fmin estimated by Cockcroft Gualt formula; cardiac ejection fraction \\>\u002F= 45% and no more than mild\u002Ftrace pericardial effusion on a recent echocardiogram; and adequate pulmonary function with oxygen saturation \\>\u002F= 92% on room air.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Second active malignancy (other than non-melanoma skin cancer or carcinoma in situ e.g. cervix, bladder, breast) that would confound interpretation of toxicity assessment or limit survival to prevent evaluation of therapy per discretion of principal investigator. Malignancies treated curatively or with hormonal therapy could be included after discussion with the principal investigator\n* Less than 28 days elapsed between prior treatment with investigational agent(s) and study enrollment\n* New York Heart Association class III-IV congestive heart failure\n* Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration\n* Known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness, except well controlled HIV with viral load \\\u003C200 copies\u002FmL on antiretroviral therapy\n* Pregnant or breastfeeding women are excluded from this study because therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants' secondary to treatment of the mother with NK cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study\n* Morphologic and\u002For cytogenetic features consistent with diagnosis of myelodysplastic syndrome on the most recent bone marrow biopsy prior to initiation of therapy\n* Serologic status reflecting active hepatitis B or C infection. Participants that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive participants will be excluded)\n* Participants with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease\n* Active central nervous system or leptomeningeal involvement by lymphoma. Participants with untreated brain metastases\u002FCNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurological and other adverse events. Participants with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast enhanced MRI imaging for at least 90 days prior to registration\n* History of active autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of systemic immunosuppressive medications other than low dose steroids \\[i.e. maximum of 15mg prednisone equivalent\\] within the last 6 months",{"count":391,"type":21},[24],"This research study is for people who have relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) that has not responded to two or more lines of therapy. The purpose of this study is to identify the recommended dose of allogeneic NK cells in combination with IL-2, Tafasitamab and Rituximab for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma.\n\nNK cells are an investigational (experimental) treatment which means they are not approved by the Food and Drug Administration (FDA). NK cells are a type of lymphocyte that's part of the body's natural immune system, and they can kill cancer cells by creating pores in the cancer cell membranes and inducing apoptosis (programmed cell death).\n\nParticipants in this study will receive lymphodepleting chemotherapy, as well as Allogeneic NK cells, Tafasitamab and Interleukin-2 (IL-2) by an intravenous (IV) infusion. Participants are expected to complete one cycle, and they may be eligible to complete a second cycle of the same regiment if they have stable disease, partial or complete remission at the end of the first cycle. Participants will be in this study for about 12 months.",[576,149,577,578,579,580,369,177,581,396],"Non Hodgkin Lymphoma","Diffuse Large B Cell Lymphoma","High-grade B-cell Lymphoma","Primary Mediastinal Large B Cell Lymphoma","Follicular Lymphoma","Marginal Zone Lymphoma",[583,584],"NK cells","Natural Killer cells","2025-11-04",{"date":587,"type":37},"2025-11-06",{"date":589,"type":21},"2025-12",{"date":591,"type":21},"2027-12",{"name":593,"class":163},"Paolo Caimi, MD",{"id":595,"slug":4,"hasResults":11,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":4,"eligibilityCriteria":599,"healthyVolunteers":11,"sex":17,"minAge":600,"maxAge":4,"enrollmentInfo":601,"targetDuration":4,"studyType":22,"phases":603,"briefSummary":604,"conditions":605,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":614,"locationsCount":117},"100520150","NCT06052826","Geriatric Assessment Guided Interventions to Accelerate Functional Recovery After CAR-T Therapy for Patients 60 Years and Older With B-cell Non-Hodgkin Lymphoma or Multiple Myeloma, GOCART Study","Geriatric (G) Assessment Guided Optimization (O) to Accelerate Functional Recovery After Chimeric Antigen Receptor T-Cell (CAR-T) Therapy for Patients 60 Years and Older With B-Cell Non-Hodgkin Lymphoma or Multiple Myeloma (GOCART)","Inclusion Criteria:\n\n* Ability to provide informed consent\n* Patient's physician must agree for patient participation. A physician may elect to provide blanket agreement for participation of any eligible CAR-T patient under their care\n* Ability to read English, or Spanish. Other languages will be acceptable with site principal investigator (PI) agreement if surveys are available and language does not preclude completing study procedures\n* Age: \\>= 60 years at the time of enrollment\n* Scheduled to receive an Food and Drug Administration (FDA)-approved CAR-T for treatment of multiple myeloma or B-cell non- Hodgkin lymphoma\n* Willing and able to complete study requirements\n* Patients expect to be able to participate at least once before lymphodepletion with trimodality optimization visits\n\nExclusion Criteria:\n\n* Prior CAR-T therapy\n* Any condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)","60 Years",{"count":602,"type":21},164,[25],"This clinical trial compares the effectiveness of geriatric assessment (GA) guided interventions to accelerate functional recovery after chimeric antigen receptor T-cell (CAR-T) therapy compared to standard of care (SOC) in patients 60 years and older with B-cell non-Hodgkin lymphoma (NHL) or multiple myeloma (MM). A large number of patients diagnosed with cancer are over the age of 60, yet most cancer treatments are developed for younger patients. Therefore, older patients may be less likely to be offered stronger treatments, such as CAR-T therapy, due to possible side effects. Geriatric assessment is a multi-dimensional health assessment tool combining patient reported and objective measures covering physical function, mental processes (cognitive), and nutrition. Pre-treatment assessments may identify weaknesses in older adults and may guide interventions for physical therapy, cognitive changes and nutrition to decrease CAR-T therapy side effects and improve care in older adults with NHL or MM.",[108,606],"Multiple Myeloma","2025-10-02",{"date":609,"type":37},"2025-10-06",{"date":611,"type":37},"2023-06-23",{"date":613,"type":21},"2026-10-05",{"name":410,"class":163},{"id":616,"slug":4,"hasResults":11,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":4,"eligibilityCriteria":620,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":621,"targetDuration":4,"studyType":22,"phases":623,"briefSummary":624,"conditions":625,"keywords":627,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":643},"100467353","NCT05365659","IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas","A Phase 1 Cohort Dose Escalation and Expansion Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas (NHL)","Inclusion Criteria:\n\n1. Males or females, ≥ 18 years of age\n2. Part 1: documented B cell NHL (any subtype except Burkitt lymphoma, Waldenström macroglobulinemia, chronic lymphocytic leukemia); previously confirmed CD19-positive if feasible\n3. Part 2: documented B cell NHL (subtypes to be determined); confirmed CD19-positive; possible expansion cohorts may include:\n\n   1. Diffuse large B cell lymphoma (including germinal center B cell type, activated B cell type)\n   2. Follicular lymphoma (including duodenal-type follicular lymphoma)\n   3. Mantle cell lymphoma\n   4. B cell lymphomas not specified\n4. If B cell NHL subtype likely to have bone marrow involvement must be willing to undergo bone marrow biopsy in the event of an on-study complete response to confirm response\n5. NHL that is relapsed, refractory to, or intolerant of existing therapy(ies) with known curative potential, or for which no standard therapy is available; must have received at least 2 prior lines of systemic therapy\n6. Must be in need of systemic treatment and not require immediate cytoreductive therapy\n7. Part 1: measurable or non-measurable disease\n8. Part 2: measurable disease according to The Revised Criteria\u002FLugano Classification\n9. Part 1: screening tumor biopsy requested, but optional; Part 2: patient must agree to screening tumor biopsy\n10. ECOG performance status 0 or 1; anticipated life expectancy ≥ 10 weeks\n11. Women of childbearing potential and fertile men agreeing to use two effective methods of contraception (including a highly effective method of contraception); women beginning 2 weeks prior to the first dose, men beginning prior to the first dose, and both continuing until 8 months after the last dose of study drug; male patients must also agree to refrain from sperm donation during this period.\n12. Ability to understand and give written informed consent\n\nExclusion Criteria:\n\n1. Women who are pregnant or intending to become pregnant before, during, or within 8 months after the last dose of study drug; women who are breastfeeding\n2. Patients documented to be CD19-negative\n3. Central nervous system (CNS) lymphoma, leptomeningeal infiltration, or spinal cord compression not controlled by prior surgery or radiotherapy; symptoms suggesting CNS involvement\n4. Part 2: History of another malignancy within 2 years, with the exception of:\n\n   1. Treated, non-melanoma skin cancers\n   2. Treated carcinoma in situ (e.g., breast, cervix)\n   3. Controlled, superficial carcinoma of the urinary bladder\n   4. T1a or b prostate carcinoma treated according to standard of care, with PSA within normal limits\n   5. Papillary thyroid carcinoma Stage I treated surgically for cure\n5. Any of the following hematologic abnormalities at baseline (transfusion allowed \\> 5 days previous):\n\n   1. Hemoglobin \\\u003C 8.0 g\u002FdL\n   2. Absolute neutrophil count \\\u003C 1,000 per mm3\n   3. Platelet count \\\u003C 75,000 per mm3\n6. Any of the following laboratory abnormalities at baseline:\n\n   1. Total bilirubin \\> 1.5 × upper limit of normal (ULN); \\> 3 × ULN if with Gilbert's Syndrome\n   2. AST or ALT \\> 3 × ULN; \\> 5 × ULN if due to hepatic involvement by tumor\n   3. Estimated GFR ≤ 60 mL\u002Fmin corrected for BSA\n   4. Albuminuria defined as urine albumin to creatinine ratio \\\u003C 30 mg\u002Fg or \\\u003C 3 mg\u002Fmmol) by spot urine albumin\n7. Any of the following coagulation parameter abnormalities at baseline unless on a stable dose of anticoagulant therapy for a prior thrombotic event:\n\n   1. PT or INR \\> 1.5 × ULN; \\> 3× ULN if anticoagulated)\n   2. PTT \\> 1.5 × ULN; \\> 3× ULN if anticoagulated\n8. Any of the following laboratory abnormalities at baseline aimed at assessing renal function:\n\n   1. Estimated glomerular filtration rate (eGFR) ≤ 60 mL\u002Fmin, corrected for BSA.\n   2. Albuminuria defined as urine albumin to creatinine ratio (UACR) ≥ 30 mg\u002Fg or ≥ 3 mg\u002Fmmol by spot urine albumin\n9. Patients with:\n\n   1. Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks unless adequately treated and stable\n   2. Active uncontrolled bleeding or a known bleeding diathesis\n10. Significant cardiovascular disease or condition, including:\n\n    1. Congestive heart failure or angina pectoris requiring therapy\n    2. Ventricular arrhythmia requiring therapy or other uncontrolled arrhythmia\n    3. Severe conduction disturbance (e.g., 3rd degree heart block)\n    4. QTc interval ≥ 480 milliseconds\n    5. Left ventricular ejection fraction below the lower limit of normal or \\\u003C 50% by MUGA scan or echocardiogram\n    6. Class III or IV cardiovascular disease according to the New York Heart Association Functional Classification\n    7. History of acute coronary syndromes (e.g., MI, unstable angina), coronary angioplasty, stenting, or bypass within 6 months\n11. Significant liver disease, including:\n\n    1. Non-infectious hepatitis\n    2. Hepatic cirrhosis (Child-Pugh Class B and Class C)\n12. Significant pulmonary disease or condition, including:\n\n    1. Significant symptomatic COPD, as assessed by the Investigator\n    2. History or any current evidence on imaging studies of interstitial lung disease, pulmonary fibrosis\n    3. History of pulmonary inflammatory disease, pneumonitis, ARDS\n    4. History of pneumonia within 6 months\n13. Significant corneal disease or condition, including history of or current evidence of keratitis\n14. Clinically significant CNS disease or condition including PML, epilepsy, vasculitis, or neurodegenerative disease. Also including TIA or stroke within 6 months\n15. Known HIV infection or AIDS\n16. Active hepatitis B virus or hepatitis C virus infection\n17. Any other serious\u002Factive\u002Funcontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever \\> 38ºC within 2 weeks\n18. Autoimmune disease or condition requiring systemic steroids or other immunosuppressive medications\n19. Unresolved Grade \\> 1 AE associated with any prior antineoplastic therapy (except persistent Grade 2 alopecia, peripheral neuropathy, decreased hemoglobin, neutropenia, lymphopenia, hypomagnesemia, and\u002For endocrine end-organ failure being adequately managed by HRT)\n20. Known or suspected hypersensitivity to any of the excipients of formulated study drug\n21. Inadequate recovery from a surgical procedure, or a major surgical procedure within 4 weeks\n22. Any other serious, life-threatening, or unstable preexisting medical condition, including significant organ system dysfunction, or clinically significant laboratory abnormality(ies)\n23. A psychiatric disorder or altered mental status that would preclude understanding of the informed consent process\n\nDrugs and Other Treatments to be Excluded:\n\n1. Receipt of:\n\n   1. Any CD19-targeted therapy within 3 months\n   2. Any tumor vaccine within 6 weeks (must have progressed if previously received)\n2. Prior autologous\u002Fallogeneic CAR-T therapy if known to be CD19-negative after\n3. Any other antineoplastic agent for the primary malignancy without delayed toxicity within 4 weeks or 5 plasma half-lives, whichever is shortest (except nitrosoureas and mitomycin C within 6 weeks)\n4. Any other investigational treatments within 4 weeks\n5. Drugs known to impair renal function, including:\n\n   1. NSAIDS within 3 days\n   2. Aminoglycoside antibiotics, amphotericin B, etc. within 1 week\n   3. Bisphosphonates within 1 month\n6. Prior solid organ transplant\n7. Allogeneic HSCT within 6 months, or:\n\n   1. If receiving immunosuppression\n   2. If with active evidence of GVHD\n8. Autologous hematopoietic stem cell transplantation (HSCT) within 3 months\n9. Radiotherapy:\n\n   1. To target lesions within 4 weeks unless progression of the lesion has been documented\n   2. To non-target lesions within 1 week\n10. Live\u002Flive-attenuated vaccines against infectious diseases within 4 weeks\n11. Immunosuppressive or systemic glucocorticoid therapy (\\> 10 mg prednisone daily or equivalent) within 2 weeks\n12. Prophylactic use of hematopoietic growth factors within 1 week\n13. Herbal therapies and supplements within 2 weeks\n14. Strong inhibitors of cytochrome P450 within 2 weeks",{"count":622,"type":21},140,[24],"This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, antineoplastic activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate, in patients with advanced B cell non-Hodgkin lymphoma (NHL).",[28,577,580,396,626],"B-cell Lymphoma",[343,628,371,629,630,631,632,633],"non-Hodgkin lymphoma","DLBCL","MCL","advance lymphoma","IKS03","lymphoma","2025-09-26",{"date":636,"type":37},"2025-10-01",{"date":638,"type":37},"2023-09-05",{"date":640,"type":21},"2028-09",{"name":642,"class":44},"Iksuda Therapeutics Ltd.",13,""]