Clinical Trial

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

Study acronym: A-319
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07371533
Lead Sponsor Shanxi Bethune Hospital
Conditions Acute Lymphocytic Leukemia
Enrollment 18 participants
Start Date 2026-02-02
Primary Completion 2027-09-30 (estimated)
Study Completion 2028-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-28