[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-leukemia-refractory\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-leukemia-refractory":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"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":18,"type":19},18,"ESTIMATED","INTERVENTIONAL",[22],"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.",[25,26,27,28,29],"Acute Leukemia","Acute Leukemia Refractory","Acute Myeloid Leukemia (AML)","ALL (Acute B-Lymphoblastic Leukemia)","Acute Leukemia in Relapse",[31,32,33,34],"ex vivo t cell depletion","TCRab depletion","CD45RA depletion","memory T cell","NOT_YET_RECRUITING","2025-07-24",{"date":38,"type":39},"2025-07-28","ACTUAL",{"date":41,"type":19},"2025-09-01",{"date":43,"type":19},"2028-09-30",{"name":45,"class":46},"Ruijin Hospital","OTHER",""]