[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560783":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":30,"responsibleParty":46,"collaborators":11,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":11,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":11,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":11,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"The First Affiliated Hospital of Xiamen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CAR-T","EXPERIMENTAL",null,[13],"Biological: CAR-T treatment",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"BIOLOGICAL","CAR-T treatment","Peripheral blood lymphocyte collection, PBMC separation, BCMA CAR-T cell preparation\u002Fstorage, lymphodepletion chemotherapy pretreatment for the subject, and BCMA CAR-T cell infusion.",[9],[21],{"name":22,"affiliation":23,"role":24},"Bing Xu","The First Aiffiliated hosptical of xiamen University","PRINCIPAL_INVESTIGATOR",[26],{"name":22,"role":27,"phone":28,"phoneExt":11,"email":29},"CONTACT","18750918842","xubingzhangjian@126.com",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Xiamen","Fujian","361000","China","CN",{"type":39,"coordinates":40},"Point",[41,42],118.08187,24.47979,{"lat":42,"lon":41},[45],{"name":22,"role":27,"phone":11,"phoneExt":11,"email":29},{"type":24,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Bing, Xu","Principal Investigator","100560783","phase-2-chimeric-antigen-receptor-modified-t-cells-targeting-bcma-for-the-treatment-of-relapsedrefractory-multiple-myeloma-100560783",false,"NCT06581640","Chimeric Antigen Receptor Modified T Cells Targeting BCMA for the Treatment of Relapsed\u002FRefractory Multiple Myeloma","A Clinical Study of the Safety and Efficacy of Chimeric Antigen Receptor-modified T Cells Targeting BCMA for the Treatment of Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Age 18-80 years, no gender restrictions;\n2. Diagnosed with refractory\u002Frelapsed multiple myeloma through physical examination, pathological examination, laboratory tests, and imaging studies;\n3. Flow cytometry or histology confirms positive BCMA expression in myeloma cells;\n4. As judged by the investigator, the expected survival time is \\>3 months;\n5. ECOG performance status score ≤2, KPS \\>60%;\n6. The patient has good liver, kidney, heart, and lung function: ALT and AST ≤2.5×ULN, those with liver involvement can be relaxed to ≤5×ULN; serum total bilirubin \\\u003C34 μmol\u002FL; creatinine clearance rate \\>30 mL\u002Fmin; heart ejection fraction (EF) ≥40%, no pericardial effusion and significant arrhythmia; indoor SpO2 ≥92%;\n7. Peripheral blood lymphocyte absolute count ALC ≥0.5 ×10\\^9\u002FL, PLT \\>30×10\\^9\u002FL, Hb \\>80 g\u002FL and has a single collection venous access, and there are no other contraindications for hematopoietic cell separation;\n8. Those with fertility must agree to use highly effective contraceptive methods;\n9. The subject or their legal guardian can understand and is willing to sign a written informed consent form voluntarily.\n\nExclusion Criteria:\n\n1. Pregnant or nursing women, as well as women planning to become pregnant within the next six months;\n2. Positive virology tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus;\n3. History of other tumors (except for those with skin or cervical in situ cancers that have been cured by radical treatment and show no evidence of disease activity);\n4. Previously received treatment targeting BCMA;\n5. Underwent autologous hematopoietic stem cell transplantation within the last 6 weeks;\n6. Presence of uncontrolled active bacterial or fungal infection;\n7. Allergic to research-related drugs or cell components;\n8. Presence of active autoimmune diseases;\n9. Currently have unstable or active ulcers or gastrointestinal bleeding;\n10. Unable to cooperate with treatment and efficacy evaluation due to mental or psychological disorders;\n11. Received other experimental drug treatments within the last 3 months;\n12. The researcher believes that for other reasons, the individual is not suitable for the clinical trial.","ALL","18 Years","80 Years",{"count":60,"type":61},5,"ESTIMATED","INTERVENTIONAL",[64],"PHASE2","To evaluate the safety and tolerability of chimeric antigen receptor gene-modified T cells targeting BCMA for the treatment of relapsed\u002Frefractory multiple myeloma",[67,68],"Multiple Myeloma","Relapsed\u002FRefractory","2024-09-23",{"date":71,"type":72},"2024-09-25","ACTUAL",{"date":74,"type":72},"2024-09-24",{"date":76,"type":61},"2028-12-31",{"name":5,"class":6},1]