protocolSection identificationModule nctId: NCT06316427, orgStudyIdInfo id: BJGBYY-IIT-LCYJ-2024-003, briefTitle: Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Acute Lymphoblastic Leukemia/Lymphoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2028-03-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Beijing GoBroad Hospital, class: OTHER, descriptionModule briefSummary: This is a single-center, open-label, non-randomized, phase I/II trial. Patients with refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) will receive autologous, prior-HSCT donor-derived or new donor-derived CD7 CAR T cells according to their HSCT history, peripheral blood leukemia burden and at their discretion. The primary objective is to learn about the safety of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase I and to learn about the efficacy of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase II. The primary endpoint is type and incidence of dose limiting toxicity (DLT) within 21 days after CD7 CAR T-cell infusion in phase I and overall response rate (ORR), which includes CR, CRh, CRi, MLFS, aplastic marrow for blood and bone marrow; central nervous system (CNS) remission; CR and PR for lymphomatous extramedullary disease according to National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia at 3 months (± 1 week) post CD7 CAR T-cell infusion in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells in phase II. A total number of 80 subjects will be enrolled., conditionsModule conditions: T-cell Acute Lymphoblastic Leukemia, conditions: Acute Lymphoblastic Leukemia, in Relapse, conditions: Refractory Acute Lymphoblastic Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Investigator Initiate Trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Autologous CD7 CAR T-cell, interventions name: Prior-HSCT donor-derived CD7 CAR T-cell, interventions name: New donor-derived CD7 CAR T-cell, outcomesModule primaryOutcomes measure: Dose-Limiting Toxicity (DLT) in phase I, primaryOutcomes measure: Overall Response Rate (ORR) in phase II, secondaryOutcomes measure: Overall Response Rate (ORR) in phase I, secondaryOutcomes measure: Safety in phase II, secondaryOutcomes measure: Progression-Free Survival (PFS) in phase II, secondaryOutcomes measure: Duration of Remission (DOR) in phase II, secondaryOutcomes measure: Overall Survival (OS) in phase II, secondaryOutcomes measure: Levels of CD7 CAR-T Cells in phase II, secondaryOutcomes measure: Levels of CAR transgene in phase II, secondaryOutcomes measure: Levels of immune cells in phase II, secondaryOutcomes measure: Levels of cytokines in phase II, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing GoBroad Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 102206, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False