[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632047":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":25,"studyPopulation":18,"armGroups":26,"interventions":32,"overallOfficials":18,"centralContacts":37,"locations":43,"responsibleParty":62,"collaborators":18,"id":64,"slug":18,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":28,"eligibilityCriteria":68,"healthyVolunteers":65,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":18,"studyType":75,"phases":76,"briefSummary":79,"conditions":80,"keywords":18,"overallStatus":45,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"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","Detailed Description:\n\nThis is a prospective, interventional Phase I\u002FII clinical study designed to evaluate the safety and efficacy of CD19\u002FCD20 CAR\u002FTRuC-T cell therapy in patients with relapsed\u002Frefractory B-cell lymphoma. A total of 20 patients aged 18-75 years with relapsed\u002Frefractory B-cell lymphoma will be enrolled. All patients must have histopathologically confirmed disease and positive CD20 expression in tumor tissue.\n\nCD19\u002FCD20 CAR\u002FTRuC-T cells will be administered as a single intravenous infusion at a total dose of 0.5-2 × 10\\^6 CAR-T cells\u002Fkg. Eligible subjects (N=20) will be assigned by the investigator to receive CD19\u002FCD20 CAR\u002FTRuC-T cell infusion.\n\nEndpoints:\n\n* Primary Endpoint:\n\n  o Incidence and severity of treatment-emergent adverse events (TEAEs) within 30 days after CD19\u002FCD20 CAR\u002FTRuC-T cell infusion.\n* Secondary Endpoints:\n\n  * Objective response rate (ORR = CR + PR) assessed within 8 weeks after infusion;\n  * Overall survival (OS) and progression-free survival (PFS) at 6 months;\n  * In vivo expansion and persistence kinetics of infused CD19\u002FCD20 CAR\u002FTRuC-T cells.",[27],{"label":28,"type":29,"description":18,"interventionNames":30},"CAR\u002FTRuC-T","EXPERIMENTAL",[31],"Combination Product: CAR\u002FTRuC-T",[33],{"type":34,"name":28,"description":35,"armGroupLabels":36,"otherNames":18},"COMBINATION_PRODUCT","Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19\u002FCD20 CAR\u002FTRuC-T cell infusion. The CAR\u002FTRuC-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.",[28],[38],{"name":39,"role":40,"phone":41,"phoneExt":18,"email":42},"LIXIN LI, PHD","CONTACT","0755-21839999","wanglixin1991@sohu.com",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Shenzhen","Guangdong","518055","China","CN",{"type":52,"coordinates":53},"Point",[54,55],114.0683,22.54554,{"lat":55,"lon":54},[58,60],{"name":59,"role":40,"phone":41,"phoneExt":18,"email":42},"LI YU, PHD",{"name":59,"role":61,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"type":63,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100632047",false,"NCT07508605","Efficacy and Safety of CD19\u002FCD20 CAR\u002FTRuC-T in Relapsed\u002FRefractory B-Cell Lymphoma","Inclusion Criteria\n\nSubjects must meet all of the following criteria to be enrolled:\n\n1. Aged 18 to 75 years, regardless of sex;\n2. Histologically confirmed relapsed\u002Frefractory B-cell lymphoma according to the 2020 World Health Organization (WHO) classification;\n3. ECOG performance status of 0-2;\n4. Expected survival of at least 3 months;\n5. CD20 expression on tumor cells confirmed by flow cytometry and\u002For immunohistochemistry;\n6. Patients who are resistant\u002Frefractory to CD19 CAR-T cell therapy or have low CD19 expression;\n7. No severe cardiac, pulmonary, hepatic, or renal disease;\n8. Able to understand and willing to sign the informed consent form for this study;\n9. No contraindications to peripheral blood mononuclear cell collection\u002Fapheresis;\n10. At least one measurable and evaluable lesion according to RECIST 1.1;\n11. Must have previously received standard first-line and second-line therapy;\n12. No antibody-based therapy within 2 weeks prior to cell therapy. Exclusion Criteria\n\nSubjects meeting any of the following criteria will be excluded:\n\n1. History of allergy to any component of the cell product;\n2. Abnormal complete blood count meeting any of the following: WBC ≤1 × 10⁹\u002FL, ANC ≤0.5 × 10⁹\u002FL, ALC ≤0.5 × 10⁹\u002FL, or PLT ≤25 × 10⁹\u002FL;\n3. Laboratory abnormalities including, but not limited to, any of the following: total serum bilirubin ≥1.5 mg\u002FdL; ALT or AST \\>2.5 times the upper limit of normal; serum creatinine ≥2.0 mg\u002FdL;\n4. New York Heart Association (NYHA) Class III or IV heart failure, or left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiography;\n5. Abnormal pulmonary function, with oxygen saturation \\\u003C92% on room air;\n6. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment;\n7. Grade 3 hypertension with poor blood pressure control despite medication;\n8. History of craniocerebral trauma, disturbance of consciousness, epilepsy, severe cerebral ischemia, or cerebral hemorrhagic disease;\n9. Presence of autoimmune disease, immunodeficiency, or other conditions requiring immunosuppressive therapy;\n10. Presence of uncontrolled active infection;\n11. Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy;\n12. Receipt of a live vaccine within 4 weeks prior to enrollment;\n13. Positive for HIV, HBV, HCV, or TPPA\u002FRPR, or HBV carrier status;\n14. History of alcohol abuse, drug abuse, or psychiatric illness;\n15. Participation in any other clinical study within 3 months prior to enrollment in this study;\n16. Female subjects meeting any of the following conditions:\n\n    1. currently pregnant or breastfeeding;\n    2. planning to become pregnant during the study period; or\n    3. of childbearing potential and unwilling or unable to use effective contraception;\n17. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.","ALL","18 Years","75 Years",{"count":73,"type":74},20,"ESTIMATED","INTERVENTIONAL",[77,78],"PHASE1","PHASE2","1. Study Title:\n\n   A Study on the Efficacy and safety of CD19\u002FCD20 CAR\u002FTRuC-T in Relapsed\u002FRefractory B-Cell Lymphoma\n2. Study Objectives:\n\n   Primary Objective: To evaluate the safety of CD19\u002FCD20 CAR\u002FTRuC-T cell therapy in patients with relapsed\u002Frefractory B-cell lymphoma.\n\n   Secondary Objective: To evaluate the efficacy of CD19\u002FCD20 CAR\u002FTRuC-T cell therapy in patients with relapsed\u002Frefractory B-cell lymphoma.\n\n   Exploratory Objective: To assess in vivo expansion and persistence of infused CD19\u002FCD20 CAR\u002FTRuC-T cells.\n3. Participant Intervention:\n\nParticipants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19\u002FCD20 CAR\u002FTRuC-T cell infusion. The CAR\u002FTRuC-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.",[81],"Relapsed\u002FRefractory B-cell Lymphoma","2026-03-27",{"date":84,"type":85},"2026-04-02","ACTUAL",{"date":87,"type":85},"2025-01-01",{"date":89,"type":74},"2027-12-30",{"name":5,"class":6},1]