NCT05909527

A Clinical Study of CAR-T Treating Relapsed or Refractory T Cell Lymphoblastic Acute Leukemia/ Lymphoma

A Single-arm, Open-label, Single-center Clinical Study: Safety and Efficacy of Anti-CD7 CAR-T in the Treatment of Relapsed or Refractory T Cell Lymphoblastic Acute Leukemia/ Lymphoma

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Guangzhou Bio-gene Technology Co., Ltd · Industry
• Sex: All
• Age: 2 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is a single arm, non blind, randomized, single center study aimed at evaluating the safety, pharmacokinetic characteristics, and preliminary efficacy of CD7 CAR-T cell injection in r/r T-ALL/LBL subjects.

Detailed description

This study is a single dose escalation and dose extension study. The main purpose of the IIT clinical trial is to evaluate the safety, tolerance, pharmacokinetic characteristics, and preliminary efficacy of CAR-T cells in r/r T-ALL/LBL subjects. The study includes two parts: the dose increasing stage (Part A) and the dose expanding stage (Part B) of CD7 CAR-T cell injection. The study plans to enroll 30 subjects, of which approximately 12-18 are planned to be enrolled in the dose escalation phase, and the remaining are planned to be enrolled in the dose escalation phase.

Conditions

• T-Cell Acute Lymphocytic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	CD7 CAR-T	A single infusion of autologous CD7 CAR-T cells administered intravenously

Timeline

• Start date: 2023-05-01
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2023-06-18
• Last updated: 2026-03-17

Locations

1 site across 1 country: China