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

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.