[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600416":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":49,"collaborators":19,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":19,"studyType":65,"phases":66,"briefSummary":69,"conditions":70,"keywords":19,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Shenzhen University General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Combination Product: CAR-T cell",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"COMBINATION_PRODUCT","CAR-T cell",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Lixin Wang, PHD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"lixin wang","CONTACT","0755-21839999","wanglixin1991@sohu.com",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Shenzhen","Other (Non U.s.)","518055","China","CN",{"type":39,"coordinates":40},"Point",[41,42],114.0683,22.54554,{"lat":42,"lon":41},[45],{"name":46,"role":27,"phone":47,"phoneExt":19,"email":48},"chuling fang","18810138318","medice2015@hotmail.com",{"type":50,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100600416","phase-1-efficacy-and-safety-of-cd19cd20-carp40-t-in-b-cell-lymphoma-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":63,"type":64},20,"ESTIMATED","INTERVENTIONAL",[67,68],"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.",[71],"Relapsed\u002FRefractory B-cell Lymphoma","2025-07-24",{"date":74,"type":75},"2025-07-31","ACTUAL",{"date":77,"type":75},"2023-10-01",{"date":79,"type":64},"2026-09-30",{"name":5,"class":6},1]