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Clinical Trial Summary

This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of human CD19 targeted DASH CAR-T Cells injection, and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.


Clinical Trial Description

Subjects with relapsed/refractory B-cell acute lymphoblastic leukemia can participate if all eligibility criteria are met. Tests required to determine eligibility including disease assessments, a physical exam, Electrocardiograph, Computed tomography(CT)/Magnetic Resonance Imaging(MRI)/Positron Emission Tomography(PET), and blood draws. Subjects will receive preconditioning chemotherapy prior to the infusion of human CD19 targeted DASH CAR-T Cells injection. After the infusion, subjects will be followed for adverse events, pharmacokinetic/pharmacodynamics characteristics, efficacy of human CD19 targeted DASH CAR-T cells. Study procedures may be performed while hospitalized. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05651191
Study type Interventional
Source Hrain Biotechnology Co., Ltd.
Contact Xuedong Sun, M.D.
Phone 0086-021-58552006
Email sunxuedong@dashengbio.com
Status Recruiting
Phase Early Phase 1
Start date October 21, 2022
Completion date September 30, 2025

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