[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595615":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":42,"collaborators":44,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":19,"eligibilityCriteria":53,"healthyVolunteers":50,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":19,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":72,"whyStopped":19,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"The Affiliated Hospital of Xuzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"The efficacy of autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy","EXPERIMENTAL","This study evaluates the efficacy and safety of sequential autologous hematopoietic stem cell transplantation (auto-HSCT) followed by CAR-T cell therapy in newly diagnosed multiple myeloma (MM) patients who achieved partial response (PR) or better but failed to attain complete response (CR) after four cycles of first-line chemotherapy, or those who achieved CR but harbored high-risk factors. The clinical data from this research will provide supportive evidence for novel therapeutic strategies in this subset of MM patients.",[13],"Other: autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy","The efficacy of autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy was evaluated in patients with multiple myeloma who either achieved partial response (PR) or better (but not complete response \\[CR\\]) after four cycles of first-line chemotherapy, or those who achieved CR but had high-risk factors.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Wei Sang,M.D.,, Ph.D.","CONTACT","13645207648","xyfylbl515@xzhmu.edu.cn",[27],{"facility":5,"status":19,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Xuzhou","Jiangsu","221002","China","CN",{"type":34,"coordinates":35},"Point",[36,37],117.28386,34.20442,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":24,"phoneExt":19,"email":25},"Wei Sang,M.D, Ph.D",{"type":43,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[45],{"name":46,"class":47},"Shuyang People's Hospital","UNKNOWN","100595615","phase-ii-clinical-study-on-the-safety-and-efficacy-of-combined-car-t-therapy-following-autologous-stem-cell-transplantation-in-multiple-myeloma-100595615",false,"NCT07034755","Phase II Clinical Study on the Safety and Efficacy of Combined CAR-T Therapy Following Autologous Stem Cell Transplantation in Multiple Myeloma","Inclusion Criteria:\n\n* Age: 18-70 years old\n* Expected survival: \\>12 weeks\n* Diagnosis: Multiple myeloma confirmed by physical examination, pathological examination, laboratory tests, and imaging studies\n* Post-chemotherapy status:\n* Patients who achieved partial response (PR) or better but failed to reach complete response (CR) after four cycles of first-line chemotherapy Patients who achieved CR after four cycles of first-line chemotherapy but have high-risk factors\n* Liver function:\n\n  * ALT and AST \\\u003C 3 times the upper limit of normal\n  * Bilirubin \\\u003C 2.0 mg\u002Fdl\n* Performance status: Karnofsky Performance Status (KPS) \\>50%\n* Organ function: No severe liver, kidney, or heart diseases\n* Stem cell transplantation: Eligible for stem cell transplantation\n* Venous access: Able to undergo venous blood sampling without contraindications to leukapheresis\n* Informed consent: Capable of understanding and voluntarily signing a written informed consent form\n\nExclusion Criteria:\n\n* Pregnancy or lactation, or women planning pregnancy within the next 6 months\n* Infectious diseases(e.g., HIV, active tuberculosis)\n* Active hepatitis B or C infection\n* Feasibility assessment showing lymphocyte-targeted transfection rate \\\u003C10% or insufficient expansion (\\\u003C5-fold) under CD3\u002FCD28 co-stimulation\n* Abnormal vital signs or inability to cooperate with examinations\n* Psychiatric\u002Fpsychological disorders precluding treatment compliance or efficacy evaluation\n* Severe allergic constitution or history of severe allergies, especially to IL-2\n* Systemic or localized severe infection requiring anti-infective therapy\n* Severe autoimmune diseases\n* Other conditions deemed unsuitable for inclusion by the investigator","ALL","18 Years","70 Years",{"count":58,"type":59},20,"ESTIMATED","INTERVENTIONAL",[62],"NA","Chimeric Antigen Receptor T-Cell (CAR-T) immunotherapy is a rapidly developing novel approach in adoptive immunotherapy for tumors in recent years. Its main characteristic lies in genetically engineering T cells to express tumor antigen-specific receptors, thereby endowing them with targeting capability, cytotoxicity, and persistence. This approach has demonstrated remarkable efficacy in relapsed\u002Frefractory hematologic malignancies. Research on multiple myeloma (MM)-specific CAR-T cells has also been progressively conducted with promising outcomes, establishing CAR-T cell therapy as an effective new treatment strategy for MM. Notably, targets such as B-cell maturation antigen (BCMA) and GPRC5D have emerged as prominent therapeutic targets for CAR-T cell therapy.\n\nTherefore, we propose to evaluate the efficacy and safety of sequential CAR-T therapy following autologous hematopoietic stem cell transplantation (ASCT) in newly diagnosed MM patients who achieve partial response (PR) or better after four cycles of first-line chemotherapy but fail to attain complete response (CR), or those who achieve CR but present with high-risk factors. The clinical data from this study will provide evidence-based support for novel treatment strategies in this subset of MM patients.",[65,66,67],"Multiple Myeloma (MM)","Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)","Chimeric Antigen Receptor T-cell",[69,70,71],"Chimeric Antigen Receptor T-Cell","allogeneic Hematopoietic Stem Cell Transplantation (HSCT)","multiple myeloma (MM)","NOT_YET_RECRUITING","2025-06-29",{"date":75,"type":76},"2025-07-02","ACTUAL",{"date":78,"type":59},"2025-07-01",{"date":80,"type":59},"2028-04-01",{"name":5,"class":6},1]