[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592014":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":36,"studyPopulation":15,"armGroups":37,"interventions":44,"overallOfficials":51,"centralContacts":56,"locations":61,"responsibleParty":81,"collaborators":15,"id":84,"slug":15,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":15,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":15,"studyType":96,"phases":97,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":64,"whyStopped":15,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Shanghai Tongji Hospital, Tongji University School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":15},[9,13,17,19,21],{"measure":10,"description":11,"timeFrame":12},"The types, frequency, and severity of treatment related adverse events","After CAR-T cell infusion, we will observe the potential adverse events, especially Cytokine Release Syndrome(CRS) and neurotoxicity Using NCI Common Terminology Criteria for Adverse Events(CTCAE) V5.0","Day1 to Week 4",{"measure":14,"description":15,"timeFrame":16},"Objective response rate(ORR)",null,"At 1,3,6,9,12,18 and 24 months post-treatment follow up",{"measure":18,"description":15,"timeFrame":16},"Duration of response (DOR)",{"measure":20,"description":15,"timeFrame":16},"Progression free survival(PFS)",{"measure":22,"description":15,"timeFrame":16},"Overall survival(OS)",[24,28],{"measure":25,"description":26,"timeFrame":27},"Kinetics of CAR-T cells","Use flow cytometry or qPCR to monitor the kinetics of CAR-T cells","Day1 to Month 3",{"measure":29,"description":15,"timeFrame":27},"Monitoring changes in IL-6, ferritin, and CRP in peripheral blood following CAR-T cell infusion",{"allocation":31,"interventionModel":32,"interventionModelDescription":15,"primaryPurpose":33,"observationalModel":15,"timePerspective":15,"maskingInfo":34},"NA","SINGLE_GROUP","TREATMENT",{"masking":35,"maskingDescription":15,"whoMasked":15},"NONE","Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are critical complications in CAR T-cell therapy. Research highlights IL-6 as a central driver of CRS, as activated CAR T-cells secrete this cytokine, which in turn stimulates monocytes to produce additional IL-6. To mitigate this risk, ssCART-19-a modified anti-CD19 CAR T-cell therapy-incorporates small hairpin RNA (shRNA) technology to silence the IL-6 gene, thereby reducing IL-6 secretion by both CAR T-cells and monocytes. This study aims to assess the safety and efficacy of the U01 (ssCART-19) therapy in patients with refractory or recurrent B-cell lymphoma .",[38],{"label":39,"type":40,"description":41,"interventionNames":42},"ssCART-19","EXPERIMENTAL","All enrolled patients in this arm will receive ssCART-19",[43],"Biological: ssCART-19",[45],{"type":46,"name":39,"description":47,"armGroupLabels":48,"otherNames":49},"BIOLOGICAL","autologous T cells transduced with a lentiviral vector containing anti-CD19 CAR and small hairpin RNA to silence the IL-6 gene",[39],[50],"anti-CD19 CAR T with small hairpin RNA to silence the IL-6 gene",[52],{"name":53,"affiliation":54,"role":55},"Wenjun Zhang, Doctor","Tongji hospital of tongji university (Shanghai tongji hospital)","PRINCIPAL_INVESTIGATOR",[57],{"name":53,"role":58,"phone":59,"phoneExt":15,"email":60},"CONTACT","+86 13918803148","zhangwenjun@tongji.edu.cn",[62],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Shanghai Tongji Hospital ( Tongji Hospital of Tongji University)","RECRUITING","Shanghai","Shanghai Municipality","200065","China","CN",{"type":71,"coordinates":72},"Point",[73,74],121.45806,31.22222,{"lat":74,"lon":73},[77,78],{"name":53,"role":58,"phone":59,"phoneExt":15,"email":60},{"name":79,"role":58,"phone":80,"phoneExt":15,"email":15},"Miao Xuan, doctor","0862166111243",{"type":55,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":15,"oldOrganization":15},"Wenjun Zhang","professor","100592014",false,"NCT06987916","Efficacy and Safety Evaluation of U01(ssCART-19) in B-Cell Lymphoma","A Single-Arm, Open-Label Clinical Study on the Efficacy and Safety of U01 (ssCART-19) in the Treatment of Relapsed or Refractory B-Cell Lymphoma","Inclusion Criteria:\n\n1. Participants must voluntarily sign the informed consent form (ICF) and demonstrate good compliance.\n2. Participants must meet the following requirements:\n\n   1. Age ≥2 years and ≤75 years at the time of signing the ICF (both sexes eligible). For minors (\\\u003C18 years), the legal guardian must sign after full disclosure; minors with decision-making capacity must co-sign with their guardians.\n   2. Confirmed diagnosis of B-cell lymphoma according to the NCCN Clinical Practice Guidelines for B-Cell Lymphomas (3rd Edition, 2024) .\n   3. Prior treatment requirements :\n\n   Failure to achieve partial response (PR) after first-line therapy, or relapse within 12 months post-first-line therapy; Relapsed\u002Frefractory B-cell lymphoma after second-line therapy (one standard chemotherapy regimen + one salvage regimen).\n\n   Prior treatments must include CD20 monoclonal antibody (unless CD20-negative tumor confirmed by the investigator) and anthracycline-based regimens .\n\n   Additionally, meet one of the following:\n\n   i. Ineligible for autologous stem cell transplantation (ASCT); ii. Refusal of ASCT; iii. Post-ASCT relapse. d) Refractory\u002Frelapsed status at screening: Relapse: Disease progression (PD) after achieving PR or complete response (CR);\n\n   Refractory:\n\n   i. No response to last-line therapy (PD during\u002Fafter treatment, or stable disease \\[SD\\] lasting \\\u003C6 months); ii. Post-ASCT relapse\u002FPD (biopsy-confirmed), including relapse\u002FPD within 12 months post-ASCT with SD\u002FPD after salvage therapy2.\n3. CD19 positivity confirmed by immunohistochemistry (IHC) of tumor tissue (preferably within 6 months).\n4. At least one measurable lesion assessed by the Lugano Lymphoma Response Criteria (Cheson 2014) .\n5. ECOG performance status score 0-3 .\n6. Adequate bone marrow reserve at screening:\n\n   Absolute lymphocyte count (ALC) ≥0.3×10⁹\u002FL ; Platelet count (PLT) ≥30×10⁹\u002FL .\n7. Adequate organ function:\n\n   AST\u002FALT ≤3×ULN (≤5×ULN if due to tumor infiltration); Total bilirubin ≤2×ULN (≤3×ULN for Gilbert syndrome with direct bilirubin ≤1.5×ULN); Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault formula); Oxygen saturation \\>91% on room air (dyspnea grade ≤1); Left ventricular ejection fraction (LVEF) ≥50% ; INR ≤1.5×ULN and APTT ≤1.5×ULN .\n8. Negative pregnancy test (blood\u002Furine) within 7 days before CAR-T infusion for women of childbearing potential. All participants must agree to use effective contraception during the study and for ≥1 year post-treatment.\n9. Adequate venous access for leukapheresis or blood collection, with no contraindications to leukapheresis.\n10. Expected survival ≥3 months .\n\nExclusion Criteria:\n\n1. Concurrent malignancies , except for:\n\n   Malignancies with disease-free survival (DFS) \\>3 years ; Carcinoma in situ ;\n2. Active viral infections :\n\n   Hepatitis B : Positive for HBe-Ab and\u002For HBc-Ab with HBV-DNA \\> lower limit of quantitation (LLOQ) ; Hepatitis C : Positive HCV-Ab with HCV-RNA \\> LLOQ ; Positive Treponema pallidum antibody (TP-Ab); Positive HIV antibody ;\n3. Uncontrolled infections (bacterial, fungal, viral, mycoplasmal, or others) as determined by the investigator;\n4. Clinically significant CNS diseases (current or history), including:\n\n   Epilepsy, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disorders, or CNS-related autoimmune diseases , deemed uncontrolled by the investigator;\n5. Cardiovascular exclusion criteria :\n\n   Cardiac angioplasty\u002Fstent placement within 12 months prior to signing ICF ; NYHA Class II-IV congestive heart failure , myocardial infarction, unstable angina, or other clinically significant cardiac history; QTe interval ≥480 ms (Fridericia correction) or LVEF \\\u003C50% at screening;\n6. Primary immunodeficiency ;\n7. Severe immediate hypersensitivity to any study drug;\n8. Live vaccine administration within 6 weeks prior to screening ;\n9. Pregnancy or lactation ;\n10. Active autoimmune diseases ;\n11. Participation in another interventional clinical trial within 30 days prior to ICF signing ;\n12. Other conditions deemed ineligible by the investigator.","ALL","2 Years","75 Years",{"count":94,"type":95},50,"ESTIMATED","INTERVENTIONAL",[98,99],"PHASE1","PHASE2","This is an open-label phase1 study to assess the safety and efficacy of U01(ssCART-19) cell therapy in the treatment of patients with refractory or recurrent B-cell lymphoma .",[102],"B Cell Lymphoma",[39,104,105],"Relapsed or Refractory B-Cell Lymphma","IL-6","2025-05-31",{"date":108,"type":109},"2025-06-05","ACTUAL",{"date":111,"type":109},"2025-04-22",{"date":113,"type":95},"2030-04-22",{"name":5,"class":6},1]