[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598397":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":19,"responsibleParty":32,"collaborators":19,"id":36,"slug":19,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":9,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":19,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":57,"whyStopped":19,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":19},{"fullName":5,"class":6},"Xuzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CAR-T","EXPERIMENTAL","CAR-T alone",[13],"Biological: CAR-T",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","The T cells are genetically modified to express a chimeric antigen receptor targeting BCMA and are infused after induction therapy at a target dose of ≥2.0×10\\^6 cells\u002Fkg",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Kailin Xu","The Affiliated Hospital oh Xuzhou Medical University","STUDY_CHAIR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},"CONTACT","+8615162166166","lihmd@163.com",{"name":22,"role":27,"phone":31,"phoneExt":19,"email":29},"15162166166",{"type":33,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Kai Lin Xu，MD","Chief Hematologist of The Affiliated Hospital of Xuzhou Medical University","100598397",false,"NCT07070960","A Study of Anti-BCMA CAR-T Therapy in Newly Diagnosed Myeloma Patients Who Are Transplant-ineligible","A Multicenter, Open-label, Single-arm Clinical Study of Anti-BCMA CAR-T Cell Therapy in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma","Inclusion Criteria:\n\n1. Age between 18 and 70 years (inclusive);\n2. Estimated life expectancy of more than 12 weeks;\n3. Diagnosis of multiple myeloma confirmed by physical examination, pathological evaluation, laboratory tests, and imaging studies;\n4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the upper limit of normal (ULN);\n5. Karnofsky Performance Status (KPS) score \\> 50%.\n6. Ineligible for ASCT.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, or women planning to become pregnant within the next six months;\n2. Transduction efficiency of targeted lymphocytes \\\u003C10%, or expansion fold \\\u003C5× under CD3\u002FCD28 co-stimulation, as determined by feasibility screening;\n3. History of severe allergies or hypersensitivity, especially to interleukin-2 (IL-2);\n4. Significant dysfunction of vital organs including the heart, lungs, or brain;\n5. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study","ALL","18 Years","70 Years",{"count":46,"type":47},35,"ESTIMATED","INTERVENTIONAL",[50],"NA","This is a prospective study of anti-BCMA CAR-T in transplant-ineligible patients with newly diagnosed multiple myeloma.",[53,54],"Multiple Myeloma","Newly Diagnosed",[53,56,9],"transplant-ineligible","NOT_YET_RECRUITING","2025-07-08",{"date":60,"type":61},"2025-07-17","ACTUAL",{"date":63,"type":47},"2025-07-15",{"date":65,"type":47},"2028-07-31",{"name":5,"class":6}]