Cabaletta Bio announced new Phase 1/2 clinical data for its CAR T cell therapy candidate, rese-cel (resecabtagene autoleucel), at the American College of Rheumatology (ACR) Convergence 2026. The data demonstrated durable, immunomodulator-free clinical improvements and a favorable safety profile across multiple autoimmune diseases, including dermatomyositis, lupus nephritis, and systemic sclerosis.
Key Details
- Dermatomyositis: 100% (6 of 6) of patients maintained an immunomodulator-free, moderate-to-major response through one year.
- Lupus Nephritis: 100% (5 of 5) of patients with a repeat kidney biopsy achieved immunomodulator-free DORIS remission and demonstrated histologic response or remission.
- Systemic Sclerosis: 71% (5 of 7) of patients achieved a rCRISS-50 response at one year, and patients with interstitial lung disease showed a 9% mean improvement in lung function (FVC).
- Safety Profile: Across 71 patients, rese-cel showed a favorable benefit-risk profile, with 94% experiencing no or only Grade 1 cytokine release syndrome (CRS).
- Regulatory Timeline: The company plans to submit a Biologics License Application (BLA) for rese-cel in myositis in the first quarter of 2028.