[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552920":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":33,"responsibleParty":49,"collaborators":31,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":31,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":31,"enrollmentInfo":60,"targetDuration":31,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":35,"whyStopped":31,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Shanghai Ming Ju Biotechnology Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Relma-cel","EXPERIMENTAL","Efficacy, safety and PK of Relma-cel will be evaluated in 1 x 10\\^8 CAR+T cells dose level",[13],"Biological: Relma-cel",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Relma-cel will be administered at one dose level:1×10\\^8 CAR+T cells",[9],[20],"CD19-targeted Chimeric Antigen Receptor(CAR) T Cells",[22],{"name":23,"affiliation":24,"role":25},"Huilai Zhang","Tianjin Cancer Hospital","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Relma-cel Medical","CONTACT","+86 21 50464201",null,"JWCAR029Medical@jwtherapeutics.com",[34],{"facility":24,"status":35,"city":36,"state":37,"zip":31,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Tianjin","Tianjin Municipality","China","CN",{"type":41,"coordinates":42},"Point",[43,44],117.17667,39.14222,{"lat":44,"lon":43},[47],{"name":23,"role":29,"phone":31,"phoneExt":31,"email":48},"zhlwgq@126.com",{"type":50,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100552920","phase-2-cd19-targeted-car-t-cells-for-relapsed-or-refractory-rr-large-b-cell-lymphoma-100552920",false,"NCT06479356","CD19-targeted CAR T Cells for Relapsed or Refractory (R\u002FR) Large B-cell Lymphoma","An Open-Label, Single-Arm Study of Relma-cel, CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for Relapsed or Refractory (R\u002FR) LBCL","Inclusion Criteria:\n\n1. ≥18 years old;\n2. Sign on the informed consent;\n3. Subjects must have histologically confirmed Large B-cell Lymphoma;\n4. Subjects had been treated with anthracyclines and rituximab(or other CD20-targeted antibodies) and had relapsed, failed to respond, or progressed after at least two lines of therapy including autologous hematopoietic stem cell transplantation(auto-HSCT);\n5. Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;\n6. Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;\n7. Adequate organ function;\n8. Adequate vascular access for leukapheresis procedure;\n9. Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;\n10. Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of Relma-cel;\n11. Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of Relma-cel.\n\nExclusion Criteria:\n\n1. Primary CNS lymphoma;\n2. History of another primary malignancy that has not been in remission for at least 2 years;\n3. Subjects has HBV,HCV,HIV or syphilis infection at the time of screening;\n4. Active deep venous thrombosis(DVT)\u002FPulmonary embolism(PE),or active DVT\u002FPE requires anti-coagulation within 3 months prior to signing the ICF;\n5. Subjects with uncontrolled systemic fungal,bacterial,viral or other infection;\n6. Presence of acute or chronic graft-versus-host disease(GVHD);\n7. History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;\n8. Pregnant or nursing woman;\n9. Subjects using of any chemotherapy,corticosteroid,experiment agents,GVHD therapies,radiation,allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;\n10. Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;\n11. Received CAR T-cell or other genetically-modified T-cell therapy previously.","ALL","18 Years",{"count":61,"type":62},12,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","This is an open-label, single-arm study to treat the adult R\u002FR Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.",[68,69],"Non-Hodgkin Lymphoma","Large B-cell Lymphoma",[71,72,73,74,75],"JWCAR029","B-Cell Malignancies","CAR T cells","Chimeric antigen receptor","Relapsed\u002FRefractory","2024-08-19",{"date":78,"type":79},"2024-08-21","ACTUAL",{"date":81,"type":79},"2024-08-15",{"date":83,"type":62},"2026-12-31",{"name":5,"class":6},1]