Cabaletta’s CABA-201 CAR-T Therapy Shows Promising Results in Lupus and Other Autoimmune Diseases

CABA-201 is a CD19-directed CAR-T therapy developed by Cabaletta Bio for treating autoimmune diseases4.

Clinical data from 10 patients across multiple autoimmune conditions showed promising efficacy and safety results9.

Three systemic lupus erythematosus (SLE) patients achieved DORIS remission, and one lupus nephritis patient had a complete renal response9.

90% of patients experienced either no cytokine release syndrome (CRS) or only Grade 1 CRS, and 90% had no immune effector cell-associated neurotoxicity syndrome (ICANS)9.

Deep B cell depletion was observed in all patients after CABA-201 infusion9.

Cabaletta is conducting multiple Phase 1/2 trials for CABA-201 in lupus, myositis, systemic sclerosis, myasthenia gravis, and pemphigus vulgaris4.

The therapy has received FDA Fast Track Designation for multiple autoimmune indications4.

As of February 2025, 50 clinical sites were actively recruiting patients, with 26 patients enrolled across the RESET clinical development program9.

The company is positioning CABA-201 as a potential one-time treatment that could lead to long-term remission without chronic immunosuppression6.

Sources:

4. https://www.cabalettabio.com/pipeline/caba-201

6. https://www.biospace.com/cabaletta-bio-receives-fda-clearance-of-ind-application-for-caba-201-for-treatment-of-systemic-lupus-erythematosus

9. https://www.cabalettabio.com/investors/news-events/press-releases/detail/125/update---cabaletta-bio-announces-updated-clinical-data