This is a multi-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.
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Parallel
Autologous CD5 CAR T-cells
DrugPeripheral blood mononuclear cells for the production of CD5 CAR T-cells from patients.
Previous stem-cell transplantation (SCT) donor-derived CD5 CAR T-cells
DrugPeripheral blood mononuclear cells for the production of CD5 CAR T cells are collected from previous SCT donors.
Newly matched donor-derived CD5 CAR T-cells
DrugPeripheral blood mononuclear cells for the production of CD5 CAR T cells are collected from newly matched donors.
Phase 1-The incidence and type of dose-limiting toxicity (DLT)
The number of patients experiencing dose-limiting toxicity (DLT) will be evaluated and the type of DLT will be recorded.
Phase 1-The incidence and severity of adverse events (AEs)
The number of patients experiencing adverse events (AEs) and the severity of AEs will be evaluated.
Phase 2-Antitumor effect
Assessment of best overall response (BOR) rate. BOR rate is the percentage of patients with the best overall response in complete response (CR), complete response with incomplete hematological recovery (CRi) or partial response (PR) based on the National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia.
Phase 1-Objective response rate (ORR)
Objective response rate (ORR) is the percentage of subjects who have achieved CR, CRi or PR based on the National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia.
Phase 1-Pharmacokinetics of CD5 CAR T cells
The proliferation and survival of CAR T cells will be measured by flow cytometry and quantitative polymerase chain reaction (qPCR).
Phase 1-The incidence and severity of adverse events (AEs).
The number of patients experiencing adverse events (AEs) and the severity of AEs will be evaluated.
Phase 1-Best overall response (BOR) rate.
BOR rate is the percentage of patients with the best overall response in CR, CRi or PR based on the National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia.
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Beijing GoBroad Hospital
Lead sponsor
The General Hospital of Western Theater Command
Collaborator
Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai
Collaborator
Shanghai Liquan Hospital
Collaborator
Central People's Hospital of Zhanjiang
Collaborator
First Affiliated Hospital of Guangxi Medical University
Collaborator
