CABA · Cabaletta Bio, Inc.

Cabaletta Bio disclosed new clinical and translational data for rese-cel (resecabtagene autoleucel) at the ASGCT 2026 Annual Meeting. The data include results from the first four patients with pemphigus vulgaris (PV) treated at the lowest dose of rese-cel without preconditioning (PC-free). As of April 2, 2026, all four patients completed at least 24 weeks of follow-up. Two of the four patients maintained drug-free compelling clinical responses through 6 months, with clinically meaningful reductions in PDAI total activity scores as early as four weeks. The safety profile was favorable: no dose-limiting toxicities (DLTs) or immune effector cell-associated neurotoxicity syndrome (ICANS); one patient experienced grade 1 cytokine release syndrome (CRS). Translational data showed similar CAR T cell expansion kinetics compared to preconditioned patients, and three of four patients had complete peripheral B cell depletion. Additionally, initial manufacturing and translational data from the first two autoimmune patients dosed with rese-cel manufactured on the automated Cellares Cell Shuttle platform were presented. As of May 6, 2026, both patients completed at least 4 weeks of follow-up. The Cell Shuttle process met all release specifications with on-time delivery, and critical product quality metrics were within established ranges. Rese-cel with automated manufacturing demonstrated similar peak expansion and B cell depletion kinetics relative to broader RESET trial data. These findings support continued exploration of higher PC-free doses in PV and other autoimmune diseases, with data anticipated in 2H26, and initial SLE data expected in 1H26 at EULAR 2026. The automated manufacturing platform is intended to improve reproducibility, scalability, and process control for potential commercial supply.