protocolSection identificationModule nctId: NCT06316856, orgStudyIdInfo id: BJGBYY-IIT-LCYJ-2024-002, briefTitle: CD5 Chimeric Antigen Receptor (CAR) T Cells in Subjects With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Beijing GoBroad Hospital, class: OTHER, descriptionModule briefSummary: This is a single-center, open-label, non-randomized, phase 1/2 study of anti-CD5 CAR-T cell therapy in patients with CD5+ relapsed or refractory T-cell malignancies. A bayesian optimal interval (BOIN) 12 design will be used to explore the optimal biological dose (OBD) from starting dose level 1: 1×10\^6 (±20%) to dose level 2: 2×10\^6 (±20%) in three cohorts (autologous, previous-transplant-donor or newly matched donor-derived CD5 CAR T cells). If the manufactured cells are not sufficient to meet the preassigned standard dose criteria, patients will be given infusion at a low dose level of 5×10\^5 (±20%) /kg. The primary objective is to evaluate the safety and tolerability of CD5 CAR T cell therapy in subjects, determine the OBD and recommend phase 2 dose (RP2D) in phase 1, and evaluate the efficacy of CD5 CAR T cell therapy in phase 2. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days, and the incidence and severity of adverse events (AEs) within 30 days after CD5 CAR T-cell infusion in phase 1, the best overall response (BOR) at 3 months (± 1 week) after CD5 CAR T-cell infusion in phase 2. A total number of 54 subjects will be enrolled., conditionsModule conditions: T-Cell Acute Lymphocytic 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, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Autologous CD5 CAR T-cells, interventions name: Previous stem-cell transplantation (SCT) donor-derived CD5 CAR T-cells, interventions name: Newly matched donor-derived CD5 CAR T-cells, outcomesModule primaryOutcomes measure: Phase 1-The incidence and type of dose-limiting toxicity (DLT), primaryOutcomes measure: Phase 1-The incidence and severity of adverse events (AEs), primaryOutcomes measure: Phase 2-Antitumor effect, secondaryOutcomes measure: Phase 1-Objective response rate (ORR), secondaryOutcomes measure: Phase 1-Pharmacokinetics of CD5 CAR T cells, secondaryOutcomes measure: Phase 1-The incidence and severity of adverse events (AEs)., secondaryOutcomes measure: Phase 1-Best overall response (BOR) rate., secondaryOutcomes measure: Phase 2-Objective response rate (ORR), secondaryOutcomes measure: Phase 2- The incidence and severity of AEs, secondaryOutcomes measure: Phase 2- Progression free survival (PFS), secondaryOutcomes measure: Phase 2- Overall survival (OS)., eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False