Cabaletta Bio Announces Updated Clinical Data Demonstrating Deepening Clinical Responses across Multiple Indications with Rese-cel at February Scientific Meetings

Core Insights - Cabaletta Bio, Inc. announced promising clinical data for resecabtagene autoleucel (rese-cel), showing significant clinical responses in patients with autoimmune diseases, including systemic lupus erythematosus (SLE), lupus nephritis (LN), and dermatomyositis, with patients off all immunosuppressants and steroids [1][2][9] Clinical Data Summary - As of January 8, 2025, 10 patients were dosed with rese-cel across the RESET clinical trials, with notable outcomes including DORIS remission in 3 out of 4 SLE patients and a complete renal response in the first LN patient [3][9] - The RESET-Myositis trial showed that the first adult dermatomyositis patient maintained a major total improvement score at 3 months post-infusion, indicating potential for drug-free remission [3][9] - In the RESET-SSc trial, the first patient demonstrated significant skin improvements and lung function enhancement after discontinuing all disease-specific therapies [9] Safety Profile - The safety profile of rese-cel appears favorable, with 90% of patients experiencing either no cytokine release syndrome (CRS) or Grade 1 CRS, and 90% experiencing no immune effector cell-associated neurotoxicity syndrome [4][9] - Deep B cell depletion was observed in all patients post-infusion, with a transitional naïve B cell phenotype upon repopulation, confirming tissue-resident B cell elimination [4][9] Clinical Development Program - Cabaletta is conducting the RESET clinical development program, which includes six Phase 1/2 trials targeting various autoimmune diseases, with an average of one patient enrolling per week since November 2024 [2][4][6] - The company plans to present the clinical data to the FDA to align on registrational trial designs in the first half of 2025 [2][10] Company Overview - Cabaletta Bio is focused on developing curative targeted cell therapies for autoimmune diseases, with rese-cel being a key investigational therapy designed to reset the immune system through deep depletion of CD19-positive B cells [6][7]