Cabaletta Bio granted Orphan Drug designation to CABA-201

Cabaletta Bio announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, for the treatment of systemic sclerosis. CABA-201 is in development as a potential treatment for autoimmune diseases driven by B cells. The RESET clinical trial program includes four Phase 1/2 trials advancing for the evaluation of CABA-201 across multiple autoimmune conditions, including the Phase 1/2 RESET-SSc trial.