[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632047":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":44,"collaborators":11,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":9,"eligibilityCriteria":51,"healthyVolunteers":48,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":11,"studyType":58,"phases":59,"briefSummary":62,"conditions":63,"keywords":11,"overallStatus":27,"whyStopped":11,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Shenzhen University General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CAR\u002FTRuC-T","EXPERIMENTAL",null,[13],"Combination Product: CAR\u002FTRuC-T",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"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.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"LIXIN LI, PHD","CONTACT","0755-21839999","wanglixin1991@sohu.com",[26],{"facility":5,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"RECRUITING","Shenzhen","Guangdong","518055","China","CN",{"type":34,"coordinates":35},"Point",[36,37],114.0683,22.54554,{"lat":37,"lon":36},[40,42],{"name":41,"role":22,"phone":23,"phoneExt":11,"email":24},"LI YU, PHD",{"name":41,"role":43,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":45,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100632047","phase-1-efficacy-and-safety-of-cd19cd20-cartruc-t-in-relapsedrefractory-b-cell-lymphoma-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":56,"type":57},20,"ESTIMATED","INTERVENTIONAL",[60,61],"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.",[64],"Relapsed\u002FRefractory B-cell Lymphoma","2026-03-27",{"date":67,"type":68},"2026-04-02","ACTUAL",{"date":70,"type":68},"2025-01-01",{"date":72,"type":57},"2027-12-30",{"name":5,"class":6},1]