T-Cell Acute Lymphocytic Leukemia Clinical Trial
Official title:
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
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.
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. ;