Cabaletta Bio Presents Positive Clinical Data and Development Updates for Rese-cel at ACR Convergence 2025

Core Insights - Cabaletta Bio, Inc. announced positive clinical data from its RESET trials for autoimmune diseases, highlighting the efficacy of rese-cel in achieving significant clinical responses without immunomodulators [1][2][3] RESET-Myositis Trial - The Phase 1/2 DM/ASyS cohort showed that all patients with sufficient follow-up met the primary endpoint, achieving major TIS responses without immunomodulators [1][4] - A registrational trial for myositis is set to begin this quarter, targeting 14 patients with a primary endpoint of moderate or major TIS response over 16 weeks [1][4] - The trial aims to address the approximately 60,000 DM patients and 15,000 ASyS patients in the U.S. who currently lack effective FDA-approved treatments [4] RESET-SSc Trial - Preliminary data from the RESET-SSc trial indicated that all patients with at least three months of follow-up achieved rCRISS-25 responses off immunomodulators and steroids [7][8] - The trial included six patients, with three experiencing low-grade CRS and one ICANS event [7] RESET-SLE Trial - In the RESET-SLE trial, three out of four SLE patients achieved DORIS, and significant renal responses were observed in lupus nephritis patients [9][10] - The trial is expanding to include a no preconditioning cohort, with initial clinical data expected in 2026 [2][11] - A total of 76 patients have been enrolled across 77 clinical trial sites globally as of October 24, 2025 [1] Rese-cel Overview - Rese-cel is an investigational CAR T cell therapy designed to reset the immune system in autoimmune diseases, administered as a single, weight-based infusion [13] - The therapy aims to transiently deplete CD19-positive cells, potentially leading to durable clinical responses without the need for chronic therapy [13][14]