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.
NCT ID: NCT06927466
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
33 participants
INTERVENTIONAL
2024-09-19
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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B019
B019
B019： Intravenous infusion, 1.0×10\^6 CAR T cell/kg-10.0×10\^6 CAR T cell/kg
Interventions
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B019
B019： Intravenous infusion, 1.0×10\^6 CAR T cell/kg-10.0×10\^6 CAR T cell/kg
Eligibility Criteria
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Inclusion Criteria
2. Meet the diagnostic criteria for recurrent or refractory acute B cell lymphoblastic leukemia；
3. Documentation of CD19/CD22 tumor expression
3\. Liver, kidney, lung and heart function meet requirements; 4. Expected survival \>3 months; 5. Women of childbearing age and all post-adolescent male participants are willing to use highly effective contraceptive methods within 1 year after the infusion of B019 injection. At the same time, the subject should promise not to donate eggs or sperm for assisted reproduction for 1 year after the cell infusion.
\-
Exclusion Criteria
2. Isolated extramedullary leukemia recurrence；
3. Subjects with ≥grade 2 acute or moderate to severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to screening;
4. Has had treatment with any prior CAR-T therapy or other therapy abandoned in protocal.
4\. Subjects who received therapy abandoned in protocal before PBMC (peripheral blood mononuclear cells) collection or before B019 injection; 5.Active other malignancy in 5 years. 6. Subjects who are positive for any of HBsAg, HBeAg, HBeAb, HBcAb, HCV-RNA, HIV EBV DNA, CMV DNA, HTLV-ab.
7\. Other situations deemed inappropriate for participation in this study by the investigator.
\-
3 Years
25 Years
ALL
No
Sponsors
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Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Yifei Cheng
Role: primary
Fei He
Role: primary
Fei Li
Role: primary
Jingbo Shao
Role: primary
Jing Chen
Role: primary
Shaoyan Hu
Role: primary
Jia Kui
Role: primary
Zhenyu Li
Role: primary
Other Identifiers
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B019-001
Identifier Type: -
Identifier Source: org_study_id
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