[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552920":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":52,"studyPopulation":45,"armGroups":53,"interventions":60,"overallOfficials":67,"centralContacts":72,"locations":78,"responsibleParty":94,"collaborators":45,"id":96,"slug":45,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":45,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":45,"enrollmentInfo":104,"targetDuration":45,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":80,"whyStopped":45,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Shanghai Ming Ju Biotechnology Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"Objective response rate (ORR) in LBCL subjects","Objective response rate (ORR) in 3 month evaluated by investigator of LBCL subjects","3 months",[14,17,21,24,27,30,33,36,39,42],{"measure":15,"description":16,"timeFrame":12},"Objective response rate (ORR)","Objective response rate (ORR) in 3 month evaluated by IRC of LBCL subjects",{"measure":18,"description":19,"timeFrame":20},"Best objective response rate ( Best ORR) in LBCL subjects","Best objective response rate (ORR) evaluated by the investigator and IRC of LBCL subjects","up to 1 year after Relma-cel infusion",{"measure":22,"description":23,"timeFrame":20},"Complete response rate (CRR) in LBCL subjects","Complete response rate (CRR) at any time points evaluated by the investigator",{"measure":25,"description":26,"timeFrame":20},"Progression-free survival (PFS)","Progression-free survival",{"measure":28,"description":29,"timeFrame":20},"Overall survival (OS)","Overall survival",{"measure":31,"description":32,"timeFrame":20},"Duration of response (DOR)","Time from first response (PR or CR) to disease progression or death from any cause",{"measure":34,"description":35,"timeFrame":20},"Pharmacokinetic(PK)-Cmax of Relma-cel","Maximum observed concentration of Relma-cel in peripheral blood",{"measure":37,"description":38,"timeFrame":20},"Pharmacokinetic(PK)-Tmax of Relma-cel","Time to maximum concentration of Relma-cel in peripheral blood",{"measure":40,"description":41,"timeFrame":20},"Pharmacokinetic(PK)-AUC of Relma-cel","Area under the concentration vs time curve of Relma-cel",{"measure":43,"description":44,"timeFrame":20},"Adverse events (AEs)","These adverse events would be measured by assessment scale method according to NCI-CTCAE v5.0 classification standard",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":45,"primaryPurpose":49,"observationalModel":45,"timePerspective":45,"maskingInfo":50},"NA","SINGLE_GROUP","TREATMENT",{"masking":51,"maskingDescription":45,"whoMasked":45},"NONE","This is an open-label, single-arm study conducted in adult subjects with R\u002FR LBCL in China to evaluate efficacy，safety and pharmacokinetics(PK) of relma-cel.\n\nRelma-cel was approved by the China National Medical Products Administration(NMPA)in September 2021(Acceptance No:CXSS2000036)for the treatment of adult patients with R\u002FR LBCL after second-line or more systemic therapy.The recommended dose is 1×10\\^8 CAR+T cells.The indication for this application is R\u002FR LBCL and the recommended dose is 1×10\\^8 CAR+T cells.",[54],{"label":55,"type":56,"description":57,"interventionNames":58},"Relma-cel","EXPERIMENTAL","Efficacy, safety and PK of Relma-cel will be evaluated in 1 x 10\\^8 CAR+T cells dose level",[59],"Biological: Relma-cel",[61],{"type":62,"name":55,"description":63,"armGroupLabels":64,"otherNames":65},"BIOLOGICAL","Relma-cel will be administered at one dose level:1×10\\^8 CAR+T cells",[55],[66],"CD19-targeted Chimeric Antigen Receptor(CAR) T Cells",[68],{"name":69,"affiliation":70,"role":71},"Huilai Zhang","Tianjin Cancer Hospital","PRINCIPAL_INVESTIGATOR",[73],{"name":74,"role":75,"phone":76,"phoneExt":45,"email":77},"Relma-cel Medical","CONTACT","+86 21 50464201","JWCAR029Medical@jwtherapeutics.com",[79],{"facility":70,"status":80,"city":81,"state":82,"zip":45,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"RECRUITING","Tianjin","Tianjin Municipality","China","CN",{"type":86,"coordinates":87},"Point",[88,89],117.17667,39.14222,{"lat":89,"lon":88},[92],{"name":69,"role":75,"phone":45,"phoneExt":45,"email":93},"zhlwgq@126.com",{"type":95,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","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":105,"type":106},12,"ESTIMATED","INTERVENTIONAL",[109],"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.",[112,113],"Non-Hodgkin Lymphoma","Large B-cell Lymphoma",[115,116,117,118,119],"JWCAR029","B-Cell Malignancies","CAR T cells","Chimeric antigen receptor","Relapsed\u002FRefractory","2024-08-19",{"date":122,"type":123},"2024-08-21","ACTUAL",{"date":125,"type":123},"2024-08-15",{"date":127,"type":106},"2026-12-31",{"name":5,"class":6},1]