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Clinical Trial Summary

The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/CD22 bispecific chimeric antigen receptors (CARs) T cell therapy for CD19-positive Acute Lymphoblastic Leukemia.


Clinical Trial Description

Primary Objectives

1. To determine the feasibility ad safety of anti-CD19/ CD22 CAR-T cells in treating patients with CD19-positive Acute Lymphoblastic Leukemia.

Secondary Objectives

1. To determine in vivo expression, dynamics and persistency of anti-CD19/CD22 CAR-T cells.

2. To determine in vivo expression of CD19-positive B cells.

3. To access the complete remission rate (ORR) in patients with ALL with 3 months after CD19/CD22 CAR-T cells infusion.

4. To investigate the favorable CD19/CD22 CAR-T cells dose and dosage regimen for the Phase II Clinical Trial. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04303520
Study type Interventional
Source The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
Contact
Status Recruiting
Phase Phase 1
Start date May 3, 2018
Completion date February 2021