[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586269":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":26,"collaborators":19,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":36,"eligibilityCriteria":37,"healthyVolunteers":32,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":19,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":19,"overallStatus":50,"whyStopped":19,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":19},{"fullName":5,"class":6},"Xuzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"allo-HSCT following CAR-T","EXPERIMENTAL","All enrolled patients will first receive CAR-T cell therapy. Patients who achieve complete remission (CR) following CAR-T infusion will subsequently undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) based on clinical assessment. The entire treatment process will be standardized and closely monitored, with follow-up evaluations focusing on adverse events, engraftment success, relapse risk, and overall survival.",[13],"Biological: All enrolled patients will first receive CAR-T cell therapy. Patients who achieve complete remission following CAR-T infusion will subsequently undergo allo-HSCT",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","All enrolled patients will first receive CAR-T cell therapy. Patients who achieve complete remission following CAR-T infusion will subsequently undergo allo-HSCT",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Kailin Xu","CONTACT","15162166166","lihmd@163.com",{"type":27,"investigatorFullName":28,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Kai Lin Xu，MD","Pro.","100586269","phase-1-car-t-cell-therapy-combined-with-allogeneic-hematopoietic-stem-cell-transplantation-for-relapsed-or-refractory-multiple-myeloma-100586269",false,"NCT06913179","CAR-T Cell Therapy Combined With Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed or Refractory Multiple Myeloma","CAR-T Cell Therapy Combined With Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed\u002FRefractory Multiple Myeloma","CAR-T-allo","Inclusion Criteria:\n\nAge between 18 and 70 years; Estimated life expectancy of more than 12 weeks; Diagnosis of multiple myeloma confirmed by physical examination, pathology, laboratory tests, and imaging studies; Patients with refractory multiple myeloma; Patients with relapsed multiple myeloma; ALT and AST \\\u003C 3 times the upper limit of normal; Total bilirubin \\\u003C 2.0 mg\u002FdL; Karnofsky Performance Status (KPS) \\> 50%; No severe dysfunction of major organs such as liver, kidney, or heart; Prior failure of autologous or allogeneic hematopoietic stem cell transplantation; Ineligible for stem cell transplantation or patients who declined transplantation due to other constraints; Voluntarily willing to receive CAR-T cell therapy for B cell-derived hematologic malignancies; Suitable for peripheral venous blood collection with no contraindications to leukapheresis; Able to understand and sign a written informed consent form.\n\nExclusion Criteria:\n\nPregnant or lactating women, or women planning pregnancy within 6 months; Presence of infectious diseases (e.g., HIV infection, active tuberculosis); Active hepatitis B or C virus infection; Pre-screening indicates peripheral blood T-cell transduction efficiency \\\u003C 10% or expansion fold \\\u003C 5× under CD3\u002FCD28 co-stimulation; Abnormal vital signs or inability to cooperate with treatment procedures; Presence of psychiatric or psychological disorders that affect treatment compliance or outcome assessment; History of severe allergy or hypersensitivity, particularly to interleukin-2 (IL-2); Systemic or localized severe infections requiring anti-infective therapy; Significant dysfunction of critical organs such as heart, lung, brain, or kidney; Patients with severe autoimmune diseases; Any other conditions deemed unsuitable for enrollment by the investigator.","ALL","18 Years","70 Years",{"count":42,"type":43},30,"ESTIMATED","INTERVENTIONAL",[46],"PHASE1","1. Study Title CAR-T Cell Therapy Combined with Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed or Refractory Multiple Myeloma\n2. Study Objective This study aims to evaluate the safety and efficacy of CAR-T cell therapy followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with relapsed or refractory multiple myeloma. The goal is to explore a novel treatment strategy for this high-risk patient population.\n3. Study Design This is a single-center, open-label, single-arm clinical study. A total of 30 patients with relapsed or refractory multiple myeloma will be enrolled. All participants will receive standardized CAR-T cell therapy followed by allo-HSCT and will undergo systematic observation and follow-up to assess therapeutic efficacy and safety.\n4. Sample Size A total of 30 patients will be enrolled in this study.\n5. Eligibility Criteria (1) Inclusion Criteria Age between 18 and 70 years; Estimated life expectancy of more than 12 weeks; Diagnosis of multiple myeloma confirmed by physical examination, pathology, laboratory tests, and imaging studies; Patients with refractory multiple myeloma; Patients with relapsed multiple myeloma; ALT and AST \\\u003C 3 times the upper limit of normal; Total bilirubin \\\u003C 2.0 mg\u002FdL; Karnofsky Performance Status (KPS) \\> 50%; No severe dysfunction of major organs such as liver, kidney, or heart; Prior failure of autologous or allogeneic hematopoietic stem cell transplantation; Ineligible for stem cell transplantation or patients who declined transplantation due to other constraints; Voluntarily willing to receive CAR-T cell therapy for B cell-derived hematologic malignancies; Suitable for peripheral venous blood collection with no contraindications to leukapheresis; Able to understand and sign a written informed consent form.\n\n(2) Exclusion Criteria Pregnant or lactating women, or women planning pregnancy within 6 months; Presence of infectious diseases (e.g., HIV infection, active tuberculosis); Active hepatitis B or C virus infection; Pre-screening indicates peripheral blood T-cell transduction efficiency \\\u003C 10% or expansion fold \\\u003C 5× under CD3\u002FCD28 co-stimulation; Abnormal vital signs or inability to cooperate with treatment procedures; Presence of psychiatric or psychological disorders that affect treatment compliance or outcome assessment; History of severe allergy or hypersensitivity, particularly to interleukin-2 (IL-2); Systemic or localized severe infections requiring anti-infective therapy; Significant dysfunction of critical organs such as heart, lung, brain, or kidney; Patients with severe autoimmune diseases; Any other conditions deemed unsuitable for enrollment by the investigator.\n\n6\\. Treatment Protocol All enrolled patients will first receive CAR-T cell therapy. Patients who achieve complete remission (CR) following CAR-T infusion will subsequently undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) based on clinical assessment. The entire treatment process will be standardized and closely monitored, with follow-up evaluations focusing on adverse events, engraftment success, relapse risk, and overall survival.",[49],"Multiple Myeloma","NOT_YET_RECRUITING","2025-03-29",{"date":53,"type":54},"2025-04-06","ACTUAL",{"date":56,"type":43},"2025-04-01",{"date":58,"type":43},"2028-03-31",{"name":5,"class":6}]