Actively Recruiting
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.
Led by Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd. · Updated on 2025-05-22
33
Participants Needed
8
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or legal guardian agrees to participate and signs informed consent
- Diagnosed with relapsed or refractory acute B-cell lymphoblastic leukemia
- Documentation of CD19/CD22 tumor expression
- Liver, kidney, lung, and heart functions meet study requirements
- Expected survival longer than 3 months
- Women of childbearing age and all post-adolescent males agree to use effective contraception for 1 year after B019 infusion and not donate eggs or sperm for assisted reproduction during that time
You will not qualify if you...
- Active central nervous system involvement by cancer
- Isolated extramedullary leukemia recurrence
- Grade 2 or higher acute or moderate to severe chronic graft-versus-host disease within 4 weeks before screening
- Prior treatment with CAR-T therapy or other treatments abandoned in protocol
- Received protocol-abandoned therapy before PBMC collection or B019 injection
- Active other malignancies within the past 5 years
- Positive for any of HBsAg, HBeAg, HBeAb, HBcAb, HCV-RNA, HIV, EBV DNA, CMV DNA, HTLV antibodies
- Any other condition deemed unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Peking University People's Hospital
Beijing, China
Actively Recruiting
2
Jiangxi Province pediatric hospital
Nanchang, China
Actively Recruiting
3
The First Affiliated Hospital of Nanchang University
Nanchang, China
Actively Recruiting
4
Children's Hospital of Shanghai
Shanghai, China
Actively Recruiting
5
Shanghai Children's Medical Center
Shanghai, China
Actively Recruiting
6
Children's Hospital of Soochow University
Suzhou, China
Actively Recruiting
7
Tongji Hospital
Wuhan, China
Actively Recruiting
8
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Actively Recruiting
Research Team
J
Jing Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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