protocolSection identificationModule nctId: NCT06343090, orgStudyIdInfo 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2042-12-01, completionDateStruct date: 2043-09-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Beijing GoBroad Hospital, class: OTHER, descriptionModule 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., conditionsModule conditions: B-cell Acute Lymphoblastic Leukemia, conditions: Acute Lymphoblastic Leukemia, in Relapse, conditions: Refractory Acute Lymphoid Leukemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: a prospective cohort study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 353, type: ESTIMATED, armsInterventionsModule interventions name: CD19 CAR T-cell, interventions name: CD22 CAR T cells, interventions name: hematopoietic stem-cell transplantation, outcomesModule primaryOutcomes 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), secondaryOutcomes measure: ORR in Sequential CAR group and CAR+HSCT group, secondaryOutcomes measure: DOR in Sequential CAR group and CAR+HSCT group, secondaryOutcomes measure: OS in Sequential CAR group and CAR+HSCT group, secondaryOutcomes measure: Adverse events (AEs) in Sequential CAR group and CAR+HSCT group, secondaryOutcomes measure: Levels of CD19 and CD22 CAR-T cells in Sequential CAR group, secondaryOutcomes measure: Levels of CD19 CAR-T cells in CAR+HSCT group, secondaryOutcomes measure: Levels of CD19 and CD22 CAR transgene in Sequential CAR group, secondaryOutcomes measure: Levels of CD19 CAR transgene in CAR+HSCT group, secondaryOutcomes measure: Quantification of B cells in Sequential CAR group and CAR+HSCT group, otherOutcomes measure: EFS in CD19 CAR T-cell infusion without consolidation therapies (Single CAR group), otherOutcomes measure: DOR in Single CAR group, otherOutcomes measure: OS in Single CAR group, otherOutcomes measure: ORR in Single CAR group, otherOutcomes measure: Adverse events (AEs) in Single CAR group, otherOutcomes measure: Levels of CD19 CAR-T cells in Single CAR group, otherOutcomes measure: Levels of CD19 CAR transgene in Single CAR group, otherOutcomes measure: Quantification of B cells in Single CAR group, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 39 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Beijing GoBroad Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 102206, country: China, contacts name: Tengyu Wang, role: CONTACT, phone: 86+18333186020, email: tengyu.wang@gohealtharo.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False