The biotechnology company Cabaletta Bio announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its novel chimeric antigen receptor (CAR) T-cell therapy CABA-201 for the treatment of patients with systemic lupus erythematosus and lupus nephritis. The company explained that CABA-201 works by diminishing CD19-positive B cells and reducing disease activity after a single infusion. To further test the efficacy of the novel therapy, researchers will initiate a new phase I/II clinical trial involving 12 patients who have lupus with or without renal involvement. “Existing therapies typically result in general immunosuppression, require chronic administration, and … can leave patients with continued disease activity, treatment-associated side effects, and impaired quality of life,” emphasized David J. Chang, MD, MPH, FACR, Chief Medical Officer of Cabaletta Bio. With relatively few treatment strategies available to patients with lupus, the company stated that CABA-201 may be a new therapeutic option to help these patients achieve durable responses.
May 25, 2023