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Brief Title: CD19 CAR-T Cells With CRS Suppression Technology for r/r CD19+ Acute Lymphoblastic Leukemia
Official Title: Chimeric Antigen Receptor T Cells Against CD19 With Cytokine Release Syndrome (CRS) Suppression Technology for Refractory/Relapsed CD19+ Acute Lymphoblastic Leukemia
Study ID: NCT03275493
Brief Summary: This is a single center,randomized ,two-cohorts, open-label ,phase 1/2 study to evaluate the efficacy and safety of T cells expressing CD19 chimeric antigen receptors treatment for relapsed/refractory CD19+ acute lymphoblastic leukemia patients.
Detailed Description: Relapsed/refractory CD19 + acute lymphoblastic leukemia patients were randomly enrolled in this study to compare the efficacy and safety between two cohorts: 1. CD19 CAR-T cells; 2. CD19 CAR-T cells with CRS suppression technology.
Minimum Age: 6 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The first affiliated hospital of soochow university, Suzhou, Jiangsu, China
Name: Xiaowen Tang, PhD
Affiliation: The First Affiliated Hospital of Soochow University
Role: PRINCIPAL_INVESTIGATOR