A Multicenter, Open-Label, Non-Randomized, Single-Arm Clinical Study of Nanobody CD5-CAR T Cell Therapy for Refractory/Relapsed T Lymphocyte Malignancies

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.

Conditions

• T-Cell Acute Lymphocytic Leukemia
• Acute Lymphoblastic Leukemia, in Relapse
• Refractory Acute Lymphoblastic Leukemia
• T-cell Malignancies

Interventions

DRUG

Autologous CD5 CAR T-cells

Peripheral blood mononuclear cells for the production of CD5 CAR T-cells from patients.

DRUG

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.

DRUG

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.

Sponsors & Collaborators

• The General Hospital of Western Theater Command

  collaborator OTHER

• Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai

  collaborator OTHER

• Shanghai Liquan Hospital

  collaborator OTHER

• Central People's Hospital of Zhanjiang

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Beijing GoBroad Hospital

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-09

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• China

Study Locations