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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: B019.
- Who it may be relevant to
- Registry conditions: Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia. Basic parameters: 3 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.
Interventions
- Biological B019
B019： Intravenous infusion, 1.0×10\^6 CAR T cell/kg-10.0×10\^6 CAR T cell/kg
Primary outcome measures
- (一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time frame: Approximately 2 years]
Secondary outcome measures (4)
- The overall response rate (ORR) [Time frame: 3 months]
- Overall Survival (OS) [Time frame: Approximately 2 years]
- PK(Pharmacokinetics):Tmax [Time frame: Approximately 2 years]
- PK(Pharmacokinetics):Cmax [Time frame: Approximately 2 years]
Eligibility criteria
Inclusion criteria
- The patient himself/herself , and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form；
- Meet the diagnostic criteria for recurrent or refractory acute B cell lymphoblastic leukemia；
- 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.
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Exclusion criteria
- Active CNS involvement by malignancy；
- Isolated extramedullary leukemia recurrence；
- Subjects with ≥grade 2 acute or moderate to severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to screening;
- 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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 8 centers
- Peking University People's Hospital — Beijing
- Jiangxi Province pediatric hospital — Nanchang
- The First Affiliated Hospital of Nanchang University — Nanchang
- Children's Hospital of Shanghai — Shanghai
- Shanghai Children's Medical Center — Shanghai
- Children's Hospital of Soochow University — Suzhou
- Tongji Hospital — Wuhan
- The Affiliated Hospital of Xuzhou Medical University — Xuzhou
Identifiers
NCT: NCT06927466 · B019-001