A Multicenter, Open-Label, Non-Randomized, Single-Arm Clinical Study of Nanobody CD5-CAR T Cell Therapy for Refractory/Relapsed T Lymphocyte Malignancies
Condition(s) studied
Investigational drug(s) / intervention(s)
Autologous CD5 CAR T-cells: Peripheral blood mononuclear cells for the production of CD5 CAR T-cells from patients.
Previous stem-cell transplantation (SCT) donor-derived CD5 CAR T-cells: Peripheral 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: Peripheral blood mononuclear cells for the production of CD5 CAR T cells are collected from newly matched donors.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Phase 1-The incidence and type of dose-limiting toxicity (DLT) — 28 days after CD5 CAR T cell infusion
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) — 30 days after CD5 CAR T cell infusion
The number of patients experiencing adverse events (AEs) and the severity of AEs will be evaluated. - Phase 2-Antitumor effect — 3 months (± 1 week) after CD5 CAR T infusion
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.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing GoBroad Hospital | Beijing | Beijing Municipality | Recruiting |
| Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai | Shanghai | Shanghai Municipality | Recruiting |
| Shanghai Liquan Hospital | Shanghai | Shanghai Municipality | Recruiting |
| The General Hospital of Western Theater Command PLA | Chengdu | Sichuan | Not Yet Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07070323 on ClinicalTrials.gov ↗ ← All trials in China