[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-leukemia-in-relapse\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-leukemia-in-relapse":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100599696","ex-vivo-t-cell-depleted-haploidentical-transplantation-bridging-with-chimeric-antigen-receptor-t-cell-therapy-and-prophylactic-memory-t-cell-infusion-for-acute-leukemia-100599696",false,"NCT07087847","Ex Vivo T-Cell-Depleted Haploidentical Transplantation Bridging With Chimeric Antigen Receptor T-cell Therapy and Prophylactic Memory T Cell Infusion for Acute Leukemia","Prospective, Single-Center, Single-Arm Clinical Study of Ex Vivo T-Cell-Depleted Haploidentical Transplantation Bridging With Chimeric Antigen Receptor T-cell Therapy and Prophylactic Memory T Cell Infusion for Acute Leukemia","Inclusion Criteria:\n\n* Diagnosis: Patients with refractory or relapsed (R\u002FR) leukemia.\n* Donor Availability: No matched sibling or unrelated donor identified through HLA typing.\n* Disease Status Post-CAR-T: including achieved complete remission (CR), minimal residual disease (MRD)-negative in bone marrow and no extramedullary relapse.\n* Normal Organ Function (meeting the following criteria): including liver function: ALT\u002FAST ≤10×ULN (upper limit of normal), total bilirubin (TBIL) ≤5×ULN, renal function: BUN and serum creatinine (Cr) ≤1.25×ULN and cardiac function: No evidence of cardiac insufficiency (confirmed by ECG and echocardiography).\n* Informed Consent: a signed informed consent form (ICF) is obtained\n\nExclusion Criteria:\n\n* Presence of any absolute contraindication to hematopoietic stem cell transplantation.\n* Severe Comorbidities with Major Organ Dysfunction","ALL","18 Years",{"count":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"NA","CAR-T therapy has evolved as a pivotal treatment for relapsed\u002Frefractory (R\u002FR) leukemia, demonstrating improved remission rates and manageable adverse events. However, over 50% of patients achieving complete remission (CR) experience relapse within one year (1-year cumulative incidence rate, CIR) due to antigen escape, CAR-T functional exhaustion, premature cell depletion, and immunosuppressive microenvironments. Novel strategies are urgently needed to sustain durable responses.\n\nBridging CAR-T therapy with TCRαβ+ and CD45RA+ cell-depleted haploidentical hematopoietic stem cell transplantation (HSCT) offers dual benefits: Graft-versus-leukemia (GvL) effects mediated by donor-derived NK cells and γδT cells target non-CAR-dependent antigens, mitigating immune evasion. Rapid hematopoietic reconstitution reduces prolonged cytopenia-related complications from prior therapies. This protocol further incorporates prophylactic CD45RO+ memory T-cell (Tm) infusion to: Minimize graft-versus-host disease (GVHD) risks compared to conventional donor lymphocyte infusion (DLI). Enhance adoptive immunity against infections\u002Frelapse via transferred donor memory immunity. We design this prospective, single-center, single-arm trial to evaluate the efficacy\u002Fsafety of this approach using the CliniMACS® system for ex vivo TCRαβ+\u002FCD45RA+ depletion in R\u002FR leukemia patients post-CAR-T.",[26,27,28,29,30],"Acute Leukemia","Acute Leukemia Refractory","Acute Myeloid Leukemia (AML)","ALL (Acute B-Lymphoblastic Leukemia)","Acute Leukemia in Relapse",[32,33,34,35],"ex vivo t cell depletion","TCRab depletion","CD45RA depletion","memory T cell","NOT_YET_RECRUITING","2025-07-24",{"date":39,"type":40},"2025-07-28","ACTUAL",{"date":42,"type":20},"2025-09-01",{"date":44,"type":20},"2028-09-30",{"name":46,"class":47},"Ruijin Hospital","OTHER"]