FDA Authorizes Clinical Trial for New Autoimmune CAR-T Cell Therapy

The U.S. Food and Drug Administration has granted Investigational New Drug status to Imviva Biotech's CTA313. This dual-targeted CAR-T cell therapy is designed for B-cell-mediated autoimmune conditions. The approval paves the way for a Phase 1b clinical study in the United States, offering a new therapeutic approach for diseases like lupus and multiple sclerosis.