[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600416":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":25,"studyPopulation":18,"armGroups":26,"interventions":33,"overallOfficials":38,"centralContacts":42,"locations":48,"responsibleParty":67,"collaborators":18,"id":69,"slug":18,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":18,"studyType":82,"phases":83,"briefSummary":86,"conditions":87,"keywords":18,"overallStatus":50,"whyStopped":18,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Shenzhen University General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"TEAEs","Adverse events during treatment","From date of initial treatment to the 30 days after treatment",[14],{"measure":15,"description":16,"timeFrame":17},"Disease-related clinical responses","Disease-related clinical responses include CR\u002FPR\u002FSD\u002FPD","From date of enrollment until the date of clinical responses,up to 2 years",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"NA","SINGLE_GROUP","HEALTH_SERVICES_RESEARCH",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE","A prospective, interventional Phase I\u002FIIa clinical study to evaluate the safety and efficacy of autocrine p40 CAR-T cells targeting dual CD19\u002FCD20 in refractory\u002Frelapsed B-cell lymphoma. A total of 20 patients aged 18 to 75 years with pathologically confirmed B-cell lymphoma (refractory\u002Frelapsed) will be enrolled. The total dose of CAR-T cells is 0.5-2×10\\^6 CAR-T cells\u002Fkg, administered as a single intravenous infusion. Eligible subjects (n=20) will be assigned by the investigator to receive either CD19CD20 CAR.p40-T injection or CD19 CAR.p40-T injection.\n\n* Primary Endpoint\\*\\*: To assess treatment-emergent adverse events (TEAEs) within 30 days after intravenous infusion of CAR-T cells.\n* Secondary Endpoints\\*\\*:\n\n  * Objective response rate (ORR=CR+PR) within 8 weeks;\n  * Overall survival (OS) and progression-free survival (PFS) at 6 months;\n  * In vivo expansion and persistence kinetics of CAR-T cells.",[27],{"label":28,"type":29,"description":30,"interventionNames":31},"CART group","EXPERIMENTAL","Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19\u002FCD20-CAR.p40-T or CD19-CAR.p40-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.",[32],"Combination Product: CAR-T cell",[34],{"type":35,"name":36,"description":30,"armGroupLabels":37,"otherNames":18},"COMBINATION_PRODUCT","CAR-T cell",[28],[39],{"name":40,"affiliation":5,"role":41},"Lixin Wang, PHD","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":18,"email":47},"lixin wang","CONTACT","0755-21839999","wanglixin1991@sohu.com",[49],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Shenzhen","Other (Non U.s.)","518055","China","CN",{"type":57,"coordinates":58},"Point",[59,60],114.0683,22.54554,{"lat":60,"lon":59},[63],{"name":64,"role":45,"phone":65,"phoneExt":18,"email":66},"chuling fang","18810138318","medice2015@hotmail.com",{"type":68,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100600416",false,"NCT07097207","Efficacy and Safety of CD19CD20-CAR.p40-T in B-cell Lymphoma","Study on the Efficacy and Safety of Autocrine p40 Chimeric Antigen Receptor T Cells Targeting CD19 and CD20 (CD19CD20-CAR.p40-T) in Refractory B-Cell Lymphoma","CAR-T","Inclusion Criteria:\n\n1. Aged between 15 and 75 years old, regardless of gender;\n2. Diagnosed with relapsed\u002Frefractory B-cell lymphoma according to the 2020 World Health Organization (WHO) diagnostic criteria;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;\n4. Expected survival time of ≥ 3 months;\n5. Confirmation of CD20 expression in tumor cells by flow cytometry\u002Fimmunohistochemistry;\n6. Patients tolerant to CD19 CAR-T cell therapy or those with low CD19 expression;\n7. No severe heart, lung, liver, or kidney diseases;\n8. Capable of understanding and willing to sign the informed consent form for this trial;\n9. No contraindications to peripheral blood apheresis for the subject;\n10. Having clearly measurable and evaluable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard;\n11. The subject must have received standard first- and second-line treatment regimens;\n12. Not having received antibody-based drug treatment within 2 weeks before cell therapy.\n\nExclusion Criteria:\n\n1. History of allergy to any component in the cell product;\n2. The following conditions in the blood routine examination: White blood cell count (WBC) ≤ 1×10⁹\u002FL, absolute neutrophil count (ANC) ≤ 0.5×10⁹\u002FL, absolute lymphocyte count (ALC) ≤ 0.5×10⁹\u002FL, platelet count (PLT) ≤ 25×10⁹\u002FL;\n3. The following conditions in laboratory tests: including but not limited to, total serum bilirubin ≥ 1.5 mg\u002Fdl; serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the upper limit of normal; serum creatinine ≥ 2.0 mg\u002Fdl;\n4. Patients with heart failure classified as grade III or IV according to the New York Heart Association (NYHA) classification criteria; or left ventricular ejection fraction (LVEF) \\\u003C 50% as detected by echocardiography;\n5. Abnormal lung function with oxygen saturation \\\u003C 92% under room air;\n6. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically severe heart diseases within 12 months before enrollment;\n7. Grade 3 hypertension with poorly controlled blood pressure despite drug treatment;\n8. History of craniocerebral trauma, disturbance of consciousness, epilepsy, severe cerebral ischemia or intracerebral hemorrhagic diseases;\n9. Patients with autoimmune diseases, immunodeficiency, or other conditions requiring immunosuppressive agent treatment;\n10. Presence of uncontrolled active infection;\n11. Previous use of any CAR-T cell product or other genetically modified T cell therapies;\n12. Vaccination with live vaccines within 4 weeks before enrollment;\n13. Subjects positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and Treponema pallidum particle agglutination assay (TPPA)\u002Frapid plasma reagin (RPR), as well as HBV carriers;\n14. History of alcohol abuse, drug abuse, or mental illness in the subject;\n15. The subject participated in any other clinical study within 3 months before joining this clinical study;\n16. Female subjects with any of the following conditions: a) Currently pregnant or breastfeeding; or b) Having a pregnancy plan during the trial period; or c) Being fertile but unable to take effective contraceptive measures;\n17. Other circumstances that, in the opinion of the investigator, make the subject unsuitable for participation in this study.","ALL","18 Years","75 Years",{"count":80,"type":81},20,"ESTIMATED","INTERVENTIONAL",[84,85],"PHASE1","PHASE2","1. Study Title:\n\n   A Study on the Efficacy and Safety of Autocrine p40 CD19\u002FCD20 Dual-Targeting Chimeric Antigen Receptor T-Cells (CD19\u002FCD20-CAR.p40-T) in Relapsed\u002FRefractory B-Cell Lymphoma\n2. Study Objectives:\n\n   * Primary Objective: To evaluate the safety of CD19\u002FCD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed\u002Frefractory B-cell lymphoma.\n   * Secondary Objective: To evaluate the efficacy of CD19\u002FCD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed\u002Frefractory B-cell lymphoma.\n3. Participant Intervention:\n\n   * Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19\u002FCD20-CAR.p40-T cell infusion or CD19 CAR.p40-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.",[88],"Relapsed\u002FRefractory B-cell Lymphoma","2025-07-24",{"date":91,"type":92},"2025-07-31","ACTUAL",{"date":94,"type":92},"2023-10-01",{"date":96,"type":81},"2026-09-30",{"name":5,"class":6},1]