[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100422092":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":29,"locations":35,"responsibleParty":53,"collaborators":20,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":20,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":20,"studyType":68,"phases":69,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Chongqing Precision Biotech Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BCMA targeted prime CAR-T cells treat","EXPERIMENTAL","Patients will be be treated with BCMA targeted prime CAR-T cells",[13],"Biological: BCMA targeted prime CAR-T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","BCMA targeted prime CAR-T cells","BCMA targeted prime CAR-T cell therapy",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"Sanbin Wang, MD","920th Hospital of Joint Logistics Support Force of People's Liberation Army of China","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":28,"role":25},"Cheng Qian, PhD","Chongqing University Cancer Hospital",[30],{"name":31,"role":32,"phone":33,"phoneExt":20,"email":34},"Zhi Yang, PhD","CONTACT","86-13206140093","yangzhi@precision-biotech.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":20,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"920th Hospital of Joint Logistics Support Force","RECRUITING","Kunming","Yunnan","China","CN",{"type":44,"coordinates":45},"Point",[46,47],102.71833,25.03889,{"lat":47,"lon":46},[50,52],{"name":23,"role":32,"phone":20,"phoneExt":20,"email":51},"Sanbin1011@163.com",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":54,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100422092","phase-1-a-clinical-research-of-bcma-targeted-prime-car-t-cell-therapy-in-relapsedrefractory-multiple-myeloma-and-plasma-cell-disease-100422092",false,"NCT04776330","a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed\u002FRefractory Multiple Myeloma and Plasma Cell Disease","Study Evaluating Safety and Efficacy of BCMA-Targeted Prime CAR-T Cell in Patients With Relapsed\u002FRefractory Multiple Myeloma and Plasma Cell Disease","Inclusion Criteria:\n\n1. Signed written informed consent;\n2. Diagnose as relapsed \u002Frefractory multiple myeloma or other plasma cell disease, and meet one of the following conditions:\n\n   1. Failed to standard chemotherapy regimens;\n   2. Relapse after complete remission, high-risk and \u002F or refractory patients ;\n   3. Relapse after hematopoietic stem cell transplantation;\n3. Evidence for cell membrane BCMA expression\n4. All genders, ages: 18 to 75 years#\n5. The expect time of survive is above 3 months;\n6. KPS\\>60\n7. No serious mental disorders ;\n8. Left ventricular ejection fraction ≥50%\n9. Sufficient hepatic function defined by ALT\u002FAST≤3 x ULN and bilirubin≤2 x ULN;\n10. Sufficient renal function defined by creatinine clearance≤2 x ULN;\n11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%; 12. With single or venous blood collection standards, and no other cell collection contraindications;\n\n13\\. Ability and willingness to adhere to the study visit schedule and all protocol requirements.\n\nExclusion Criteria:\n\n1. Previous history of other malignancy;\n2. Presence of uncontrolled active infection;\n3. Evidence of disorder that need the treatment by glucocorticoids;\n4. Active or chronic GVHD\n5. The patients treatment by inhibitor of T cell\n6. Pregnant or breasting-feeding women;\n7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.","ALL","18 Years","75 Years",{"count":66,"type":67},80,"ESTIMATED","INTERVENTIONAL",[70,71],"PHASE1","PHASE2","This is a single arm study to evaluate the efficacy and safety of BCMA-targeted prime CAR-T cells therapy for patients with relapsed\u002Frefractory Multiple Myeloma.",[74,75,76],"Multiple Myeloma","Neoplasm, Plasma Cell","Multiple Myeloma in Relapse",[74,78,79],"BCMA","prime Chimeric Antigen Receptor T Cell","2025-02-23",{"date":82,"type":83},"2025-02-25","ACTUAL",{"date":85,"type":83},"2021-03-07",{"date":87,"type":67},"2027-07-01",{"name":5,"class":6},1]