NCT07347860

Clinical Study of (A-319) in the Treatment of Active Rheumatoid Arthritis

Clinical Study of Recombinant Anti-CD19m-CD3 Antibody Injection (A-319) in the Treatment of Active Rheumatoid Arthritis

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study was to evaluate the safety and tolerability of A-319 in patients with active rheumatoid arthritis.

Detailed description

Active rheumatoid arthritis (RA) is an autoimmune disease characterized by erosive arthritis as its primary clinical manifestation. A-319 is a recombinant CD19xCD3 bispecific antibody that activates T cells in vivo and targets and kills pathogenic B cells. A-319 is currently in clinical trials for B-cell hematologic malignancies. Preclinical results in animal models of systemic lupus erythematosus (SLE) and RA have also demonstrated that A-319 can alleviate or eliminate autoimmune disease-related symptoms and progression by depleting pathogenic B cells in individuals with autoimmune diseases. This investigator-initiated trial (IIT) evaluated the safety, tolerability, pharmacokinetic profile, biological markers, and preliminary efficacy of A-319 in the treatment of patients with rheumatoid arthritis (RA) who have refractory responses to at least two different therapies with different mechanisms of action.

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
BIOLOGICAL	A-319	A-319 will be dosed according to the assigned group.

Timeline

• Start date: 2026-01-08
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: China