Evaluating B019 Injection for Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
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.
This study is testing a new injection called B019 to see if it can help people with relapsed or hard-to-treat B-cell acute lymphoblastic leukemia feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 3 Years to 25 Years |
| Sex | All |
| Sponsor | Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd. Industry-sponsored |
| Drugs / interventions | CAR-T |
| Locations | 8 sites (Beijing and 7 other locations) |
| Trial ID | NCT06927466 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess the safety, tolerability, and preliminary efficacy of B019 injection in patients diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia. Participants will receive the B019 treatment, and their responses will be closely monitored to gather data on its effects. The study will include patients who meet specific diagnostic criteria and have documented tumor expression of CD19/CD22. The trial is designed to provide insights into the potential of B019 as a therapeutic option for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with relapsed or refractory B-cell acute lymphoblastic leukemia who meet the inclusion criteria.
Not a fit: Patients with active CNS involvement by malignancy or those who have had prior CAR-T therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with limited treatment choices.
How similar studies have performed: While this approach is novel, similar studies targeting B-cell malignancies have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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. \-
Where this trial is running
Beijing and 7 other locations
- Peking University People's Hospital — Beijing, China (Recruiting)
- Jiangxi Province pediatric hospital — Nanchang, China (Recruiting)
- The First Affiliated Hospital of Nanchang University — Nanchang, China (Recruiting)
- Children's Hospital of Shanghai — Shanghai, China (Recruiting)
- Shanghai Children's Medical Center — Shanghai, China (Recruiting)
- Children's Hospital of Soochow University — Suzhou, China (Recruiting)
- Tongji Hospital — Wuhan, China (Recruiting)
- The Affiliated Hospital of Xuzhou Medical University — Xuzhou, China (Recruiting)
Study contacts
- Study coordinator: Jing Chen
- Email: chenjing@scmc.com.cn
- Phone: 0086-021-38626161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.