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ACTIVE NOT RECRUITING
NCT03919240
PHASE1/PHASE2

CAR-T Cell Therapy Targeting to CD19 for R/R ALL

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

Summary

Refractory and relapsed (R/R) acute lymphoblastic leukemia (ALL) patients with active disease always have a dismal outcome. Chimeric antigen receptor (CAR) T-cell therapy targeting to Cluster of Differentiation Antigen 19 (CD19) has been proved as a potent approach to attain remission in B-cell R/R patients. Therefore, the investigators conduct atrial to evaluate the the efficacy and safety of locally producing CAR T cells targeting CD19, and to analyze the outcome of enrolled B-cell ALL patients with active disease or persistent residual disease.

Official title: CD19-targeting Chimeric Antigen Receptor T-cell Therapy for Patients with Refractory and Relapsed B-cell Acute Lymphoblastic Leukemia

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

196

Start Date

2015-12-01

Completion Date

2025-12-31

Last Updated

2024-10-24

Healthy Volunteers

No

Interventions

BIOLOGICAL

CAR T-cell therapy

Patients enrolled will receive infusion of CD19-targeting CAR T-cells with a target dose of 5\~10×10E6/kg of recipient weight, after the preparative regimen consisted of fludarabin (30mg/m2, day -5 to -3) and cyclophosphamide (300mg/m2, day -5 to -3).

Locations (1)

The Fisrt Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China