nctId: NCT06343090 id: BJGBYY-IIT-LCYJ-2023-003 briefTitle: Clinical Trial of CD19 and CD22 CAR Sequential Therapy Versus Single CD19 CAR Bridging to HSCT for r/r B-ALL Patients overallStatus: RECRUITING date: 2024-04-12 date: 2042-12-01 date: 2043-09-30 date: 2024-04-02 date: 2024-04-18 name: Beijing GoBroad Hospital class: OTHER briefSummary: This is a single-center, open-label, non-randomized, two-arm, non-inferior trial. Patients with r/r B-ALL would be assigned to the CD19 CAR and CD22 CAR T-cell sequential infusion group (Sequential CAR, Arm-1) and the CD19 CAR T-cell infusion bridging to hematopoietic stem cell transplantation group (CAR+HSCT, Arm-2), according their own discretion. Patients would be also allowed to assigned to the CD19 CAR T-cell infusion without consolidation therapies group (Single CAR, additional placebo arm) according their own discretion. The primary objective is to prospectively evaluate and compare the efficacy of CD19 CAR and CD22 CAR T cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT in the treatment of r/r B-ALL. The primary endpoint is event-free survival of children and adolescent and young adult (AYA) with r/r B-ALL a treated with CD19 CAR and CD22 CAR T-cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT. A total number of 353 subjects will be enrolled. conditions: B-cell Acute Lymphoblastic Leukemia conditions: Acute Lymphoblastic Leukemia, in Relapse conditions: Refractory Acute Lymphoid Leukemia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a prospective cohort study primaryPurpose: TREATMENT masking: NONE count: 353 type: ESTIMATED name: CD19 CAR T-cell name: CD22 CAR T cells name: hematopoietic stem-cell transplantation measure: EFS in CD19 CAR and CD22 CAR-T sequential infusion (Sequential CAR group) and CD19 CAR T-cell infusion bridging to HSCT (CAR+HSCT group) measure: ORR in Sequential CAR group and CAR+HSCT group measure: DOR in Sequential CAR group and CAR+HSCT group measure: OS in Sequential CAR group and CAR+HSCT group measure: Adverse events (AEs) in Sequential CAR group and CAR+HSCT group measure: Levels of CD19 and CD22 CAR-T cells in Sequential CAR group measure: Levels of CD19 CAR-T cells in CAR+HSCT group measure: Levels of CD19 and CD22 CAR transgene in Sequential CAR group measure: Levels of CD19 CAR transgene in CAR+HSCT group measure: Quantification of B cells in Sequential CAR group and CAR+HSCT group measure: EFS in CD19 CAR T-cell infusion without consolidation therapies (Single CAR group) measure: DOR in Single CAR group measure: OS in Single CAR group measure: ORR in Single CAR group measure: Adverse events (AEs) in Single CAR group measure: Levels of CD19 CAR-T cells in Single CAR group measure: Levels of CD19 CAR transgene in Single CAR group measure: Quantification of B cells in Single CAR group sex: ALL minimumAge: 1 Year maximumAge: 39 Years stdAges: CHILD stdAges: ADULT facility: Beijing GoBroad Hospital status: RECRUITING city: Beijing state: Beijing zip: 102206 country: China name: Tengyu Wang role: CONTACT phone: 86+18333186020 email: tengyu.wang@gohealtharo.com lat: 39.9075 lon: 116.39723 hasResults: False