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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Leukemia
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

NCT number NCT05909527
Study type Interventional
Source Guangzhou Bio-gene Technology Co., Ltd
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date May 1, 2023
Completion date August 1, 2028