The U.S. Food and Drug Administration (FDA has cleared the investigational new drug (IND) application for Allogene Therapeutics’ ALLO-329, an investigational allogenic CAR-T cell therapy. Researchers are preparing to a initiate the  Phase 1 RESOLUTION trial in mid-2025 for people with autoimmune diseases, including systemic lupus erythematosus (SLE), lupus nephritis (LN), idiopathic inflammatory myopathies, and systemic sclerosis. 

ALLO-329 is designed to target both CD19+ B cells and CD70+ activated T cells. The therapy utilizes CRISPR-based specific integration to enable dual CAR expression and incorporates Allogene’s clinically validated Dagger® technology. This technology is aimed at minimizing or eliminating the need for lymphodepletion, a pre-treatment regimen which can pose a significant barrier to CAR-T cell therapy. 

Continue to follow the Lupus Foundation of America for updates on lupus drug developments and clinical trials. Learn more about medications used to treat lupus.