NCT07371533

Clinical Study of Recombinant Anti-CD19m-CD3 Antibody Injection (A-319)

Recombinant Anti-CD19m-CD3 Antibody Injection (A-319) for Refractory/Relapsed or MRD-Positive After Induction Chemotherapy Acute B-Cell Lymphoblastic Leukemia (B-ALL) Clinical Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Shanxi Bethune Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory study with an open-label, single-arm, single-center design. It plans to enroll subjects with refractory/relapsed acute B-cell lymphoblastic leukemia (B-ALL), or treatment-naive or previously treated B-ALL subjects who achieved complete remission (CR) after induction chemotherapy but still have positive minimal residual disease (MRD). The primary objectives are to preliminarily evaluate the safety, tolerability, pharmacokinetics, biology, preliminary efficacy, and immunogenicity of A-319 subcutaneous injection.

Conditions

• Acute Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Treatment with A319	The maximum duration of treatment is no more than 4 cycles (one cycle is defined as: 1 week of induction + 3 weeks of treatment + 2 weeks of drug withdrawal). During the 1st week, induction doses of 0.15 μg/kg, 0.45 μg/kg, and 0.9 μg/kg will be administered subcutaneously on Days 1, 3, and 5 respectively. From Weeks 2 to 4, the corresponding treatment dose will be administered subcutaneously on Days 1, 3, and 5 of each week. Weeks 5 to 6 will be the drug withdrawal period.

Timeline

• Start date: 2026-02-02
• Primary completion: 2027-09-30
• Completion: 2028-01-31
• First posted: 2026-01-28
• Last updated: 2026-01-28