[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599696":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":40,"collaborators":44,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":20,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":20,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":70,"overallStatus":75,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TCRαβ+\u002FCD45RA+ depleted haplo-HSCT bridging with CAR-T","EXPERIMENTAL","For patients with refractory\u002Frelapsed (R\u002FR) leukemia:\n\nApproximately 28 days post-CAR-T therapy, a hematologic assessment will be performed. Eligible patients meeting the inclusion criteria will subsequently undergo TCRαβ+\u002FCD45RA+-depleted haploidentical hematopoietic stem cell transplantation (haplo-HSCT).",[13],"Biological: TCRαβ+\u002FCD45RA+depleted haploidentical hematopoietic stem cell transplantation (haplo-HSCT)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","TCRαβ+\u002FCD45RA+depleted haploidentical hematopoietic stem cell transplantation (haplo-HSCT)","Approximately 28 days post-CAR-T therapy, a hematologic assessment will be performed. Eligible patients meeting the inclusion criteria will subsequently undergo TCRαβ+\u002FCD45RA+depleted haploidentical hematopoietic stem cell transplantation (haplo-HSCT).Collect peripheral blood stem cells (PBSC) from the haplo-donor.Split the graft into two fractions at a 9:1 ratio, 90% fraction: subject to TCRαβ+ T-cell depletion, 10% fraction: subject to CD45RA+ T-cell depletion. Primary graft (TCRαβ+depleted and partial CD45RA+ depleted): Freshly infused into the recipient. Residual CD45RA-depleted lymphocytes: Cryopreserved for prophylactic donor lymphocyte infusion (DLI) as needed.",[9],null,[22],{"facility":23,"status":20,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Ruijin Hospital, Shanghai Jiao Tong University School of Medicine","Shanghai","Shanghai Municipality","200025","China","CN",{"type":30,"coordinates":31},"Point",[32,33],121.45806,31.22222,{"lat":33,"lon":32},[36],{"name":37,"role":38,"phone":20,"phoneExt":39,"email":20},"Dr. Jiang, PhD, Medical Degree","CONTACT","+86 1366155695",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Hu Xiaoxia","Professor of hematology",[45],{"name":46,"class":47},"Miltenyi Biotec B.V. & Co. KG","INDUSTRY","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":58,"type":59},18,"ESTIMATED","INTERVENTIONAL",[62],"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.",[65,66,67,68,69],"Acute Leukemia","Acute Leukemia Refractory","Acute Myeloid Leukemia (AML)","ALL (Acute B-Lymphoblastic Leukemia)","Acute Leukemia in Relapse",[71,72,73,74],"ex vivo t cell depletion","TCRab depletion","CD45RA depletion","memory T cell","NOT_YET_RECRUITING","2025-07-24",{"date":78,"type":79},"2025-07-28","ACTUAL",{"date":81,"type":59},"2025-09-01",{"date":83,"type":59},"2028-09-30",{"name":5,"class":6},1]