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Clinical Trial Summary

To evaluate the safety and tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive B-cell acute lymphoblastic leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.


Clinical Trial Description

Participants with relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, electrocardiograph and blood draws. Participants receive chemotherapy prior to the infusion of CD19 CAR+ T cells. After the infusion, participants will be followed for side effects and effect of CD19 CAR+ T cells. Study procedures may be performed while hospitalized. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03798509
Study type Interventional
Source Hrain Biotechnology Co., Ltd.
Contact Hongliang Fang, doctor
Phone 021-58552006
Email fanghongliang@dashengbio.com
Status Recruiting
Phase Phase 1
Start date March 13, 2019
Completion date January 2024

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