[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544191":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":20,"centralContacts":26,"locations":34,"responsibleParty":48,"collaborators":20,"id":52,"slug":20,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":20,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":20,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CAR-T following ASCT","EXPERIMENTAL","Participants will receive high-dose chemotherapy followed by stem-cell infusion, and a fixed dose of CAR-T cells will be infused.",[13,14],"Other: autologous stem-cell transplantation","Drug: Relmacabtagene autoleucel (relma-cel)",[16,21],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"autologous stem-cell transplantation","high-dose chemotherapy and autologous stem-cell transplantation (HDT\u002FASCT)",[9],null,{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":20},"DRUG","Relmacabtagene autoleucel (relma-cel)","relma-cel (CD19 CAR-T cell)infusion on day 3(±1d) after ASCT with a fixed dose of 100X10\\^6.",[9],[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Weili Zhao","CONTACT","+862164370045","zwl_trial@163.com",{"name":33,"role":29,"phone":30,"phoneExt":20,"email":20},"Li Wang",[35],{"facility":36,"status":37,"city":38,"state":20,"zip":20,"country":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Ruijin Hospital, Shanghai Jiao Tong University School of Medicine","RECRUITING","Shanghai","China",{"type":41,"coordinates":42},"Point",[43,44],121.45806,31.22222,{"lat":44,"lon":43},[47],{"name":28,"role":29,"phone":20,"phoneExt":20,"email":31},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Zhao Weili","Professor","100544191",false,"NCT06365671","CAR-T Following ASCT for Relapsed\u002FRefractory B-Cell Non-Hodgkin's Lymphoma (R\u002FR B-NHL) With High-Risk Prognostic Factors","A Single-Arm Clinical Study of CD19 CAR-T Following ASCT for Relapsed\u002FRefractory B-Cell Non-Hodgkin's Lymphoma (R\u002FR B-NHL) With High-Risk Prognostic Factors","Inclusion Criteria:\n\n1. Histologically confirmed B-cell non-Hodgkin's lymphoma including the following types\n\n   * diffuse large B-cell lymphoma\n   * high-grade B-cell lymphoma with or without MYC and BLC2 and\u002For BCL6 rearrangement\n   * transformed lymphoma\n   * primary mediastinal large B-cell lymphoma\n   * follicular lymphoma (FL)\n2. Relapsed or refractory diseases fulfilling one of the following criteria (individuals must have received anti-CD20 monoclonal antibody and anthracycline-containing chemotherapy regimen)\n\n   * Primary refractory disease, defined as disease progression after first-line immunochemotherapy or disease progression within 6 weeks of the end of the last chemotherapy\n   * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n   * Partial response (PR) as best response after at least 6 cycles of first-line therapy (biopsy-proven residual disease is needed for individuals with Deauville score of 4)\n   * PR as best response after at least 2 cycles of second-line therapy\n   * Disease relapse ≤12 months after the completion of first-line immunochemotherapy\n   * Relapsed or refractory disease after ≥2 lines of chemotherapy\n3. Presence of at least one of the following high-risk prognostic factors: (1) extranodal involvement; (2) maximum diameter of the bulky mass ≥5 cm; (3) TP53 gene alterations\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n5. Eligible for HDCT\u002FASCT based on the investigator's assessment and are scheduled to undergo an ASCT sequential CAR-T treatment regimen\n6. Adequate renal and hepatic function defined as:\n\n   * Serum alanine aminotransferase (ALT\u002FAST) ≤ 3 upper limit of normal (ULN)\n   * Total bilirubin ≤1.5 mg\u002FdL(\\\u003C3 times ULN in patients with Gilbert's syndrome, cholestasis due to hepatoportal compression adenopathy, biliary obstruction in patients with liver involvement or lymphoma)\n   * Serum creatinine ≤1.5 ULN, or creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL\u002Fmin\n7. Cardiac ejection fraction ≥ 40%\n8. Baseline oxygen saturation \\> 95% on room air\n9. Life expectancy ≥3 months\n\nExclusion Criteria:\n\n1. History of autologous or allogeneic stem cell transplantation\n2. Active HBV or HCV infection, defined as HBV-DNA or HCV-DNA levels above the normal upper limit, with or without abnormal liver function. Individuals with positive HBsAg or HBcAb should receive antiviral prophylaxis for at least 12 months after CAR-T cells infusion.\n3. Presence of uncontrolled infection, cardio-cerebrovascular disease，coagulopathy, or connective tissue disease.\n4. History of HIV infection\n5. Prior chimeric antigen receptor cellular immunotherapy targeting CD19\n6. Pregnant or lactating patients","ALL","18 Years",{"count":61,"type":62},16,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","Clinical trial for the safety and efficacy of CD19 CAR-T following autologous hematopoietic stem cell transplantation (ASCT) for Relapsed\u002FRefractory B-Cell Non-Hodgkin's Lymphoma (R\u002FR B-NHL) with High-Risk Prognostic Factors",[68],"B-cell Non Hodgkin Lymphoma","2026-01-03",{"date":71,"type":72},"2026-01-06","ACTUAL",{"date":74,"type":72},"2024-04-16",{"date":76,"type":62},"2027-04",{"name":5,"class":6},1]