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.

Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd.

Status and phase: Enrolling; Phase 1

Conditions: Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

Treatments: Biological: B019

Study type: Interventional

Funder types: Industry

Identifiers

NCT06927466

B019-001

Details and patient eligibility

About

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

Enrollment: 33 estimated patients

Sex: All

Ages: 3 to 25 years old

Volunteers: No Healthy Volunteers

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

4. 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.

5. 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.

6. Other situations deemed inappropriate for participation in this study by the investigator.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

B019

Experimental group

Treatment:

Biological: B019