Investigational CAR T Cell Gets Fast Tracked by U.S. FDA

May 1, 2023

The LRA and our clinical arm Lupus Therapeutics are pleased to share good news from Cabaletta Bio, Inc. that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for CABA-201, a CAR T cell investigational therapy in development to treat systemic lupus erythematosus and lupus nephritis – a common lupus complication causing inflammation of the kidney.  

The FDA defines Fast Track as “a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.”  

Previous results of a small study published in the prestigious journal Nature Medicine suggested that a type of immune cell therapy called chimeric antigen receptor (CAR) T cell therapy could become a highly effective therapy for SLE patients who do not respond to current lupus treatments.  CD19 CAR T cells are T cells that have been engineered to target and destroy harmful B cells with a unique protein – CD19 – on their surface. 

The research that provided the foundation for the development of CAR T cell therapy in lupus was funded in part by the Lupus Research Alliance (LRA) 2015 Lupus Innovation Award grant to Dr. Marko Radic from the University of Tennessee Health Science Center. Dr. Radic’s work showed that CD19 CAR T cell therapy effectively depleted the harmful B cells in mice with lupus and induces disease remission. B cells are immune cells responsible for causing many of the symptoms of SLE, as these cells produce autoantibodies that attack the body’s own tissues and organs. 

Source: Cabaletta Press Release May 1, 2023