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A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.
Sponsor: Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.
Summary
The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.
Key Details
Gender
All
Age Range
3 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
33
Start Date
2024-09-19
Completion Date
2028-06-30
Last Updated
2025-05-22
Healthy Volunteers
No
Interventions
B019
B019: Intravenous infusion, 1.0×10\^6 CAR T cell/kg-10.0×10\^6 CAR T cell/kg
Locations (8)
Peking University People's Hospital
Beijing, China
Jiangxi Province pediatric hospital
Nanchang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Children's Hospital of Shanghai
Shanghai, China
Shanghai Children's Medical Center
Shanghai, China
Children's Hospital of Soochow University
Suzhou, China
Tongji Hospital
Wuhan, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China