NCT06927466 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 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd. |
| Condition | Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2024-09-19 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 33 participants in total. It began in 2024-09-19 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.
Eligibility 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. \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06927466 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 25 Years, studying Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06927466 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06927466 currently recruiting?
Yes, NCT06927466 is actively recruiting participants. Contact the research team at chenjing@scmc.com.cn for enrollment information.
Where is the NCT06927466 trial being conducted?
This trial is being conducted at Beijing, China, Nanchang, China, Nanchang, China, Shanghai, China and 4 additional locations.
Who is sponsoring the NCT06927466 clinical trial?
NCT06927466 is sponsored by Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.. The trial plans to enroll 33 participants.
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