NCT06316856

CD5 Chimeric Antigen Receptor (CAR) T Cells in Subjects With Relapsed or Refractory T-cell Malignancies

CD5 Chimeric Antigen Receptors (CAR) T Cells in Subjects With Relapsed or Refractory T-Cell Malignancies: a Multi-center, Open-label, Non-randomized, Phase 1/2 Clinical Trial

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Beijing GoBroad Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-06-18
• Primary completion: 2026-06-30
• Completion: 2026-12-30
• First posted: 2024-03-19
• Last updated: 2026-03-10

Locations

4 sites across 1 country: China