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# Cabaletta Bio Gains Fast Track on CABA-201
- URL: https://www.fdaweb.com/cabaletta-bio-gains-fast-track-on-caba-201/
- Published: 2024-01-08T12:00:00.000Z
- Updated: 2026-09-14T14:19:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156095

FDA has granted Cabaletta Bio a fast track designation for CABA-201, an investigational 4-1BB-containing CD19-CAR T cell therapy for treating patients with dermatomyositis to improve disease activity and for treating patients with systemic sclerosis (SSc) to improve associated organ dysfunction. “CABA-201 is designed to deeply and transiently deplete CD19-positive B cells following a one-time infusion, which may enable an “immune system reset” with the potential for durable remission off therapy in patients with autoimmune diseases,” the company says.

Dermatomyositis is an autoimmune disease that can lead to severe functional impairment, according to the company. It typically presents with a skin rash along with muscle inflammation and weakness. SSc is described as a rare and potentially fatal chronic autoimmune disease characterized by progressive skin and internal organ fibrosis that can be life-threatening, including interstitial lung disease, pulmonary hypertension, and scleroderma renal crisis.