Evaluating B019 Injection for Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

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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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Where it's running

• 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

Study contacts

• Study coordinator: Jing Chen
• Email: chenjing@scmc.com.cn
• Phone: 0086-021-38626161

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• GN001 therapy for B-cell cancers that have come back or not responding

  This study tests GN001, a CAR T therapy created inside the body, in adults with CD19-positive relapsed or refractory B-cell non-Hodgkin lymphoma or B-cell acute lymphoblastic leukemia to see if it is safe and tolerable at different doses.

  Recruiting at 2 sites Phase 1 Department of Hematology,Rheumatology and Immunology,Pu'er People's Hospital · Kunming, Yunnan and 1 other locations · NCT07910708

• CD19 targeted CAR T cell therapy for children with relapsed or refractory B cell leukemia and lymphoma

  This study is testing a new CAR T cell therapy for children with tough-to-treat B cell leukemia and lymphoma to see if it can help them feel better.

  Recruiting at 14 sites Phase 1 Autolus Limited · Los Angeles, California and 13 other locations · NCT06173518

• Effects of CART19 Cells in Patients with Certain Blood Cancers

  This study is testing a new treatment using modified immune cells to see if it can help adults with certain types of blood cancers that haven't responded to other therapies.

  Recruiting Phase 1 Institute of Hematology and Blood Transfusion, Czech Republic · Prague · NCT05054257

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.