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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.

RecruitingPhase 1Ages 3 Years - 25 YearsAllShanghai Pharmaceutical Group Biological Therapy …
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In plain words

What the trial is, and whether it could suit you

The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. The patient himself/herself , and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form; 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: 1. Active CNS involvement by malignancy; 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. \-
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What it tests

  • B019
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Where

8 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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