Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT04303520
Brief 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.
Detailed 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:
NCT04303520
Study Brief:
Protocol Section:
NCT04303520