Cabaletta Bio Presents Preconditioning-Free Clinical Data and Automated Manufacturing Translational Data for Rese-Cel
CABA
Published on 05/14/2026 at 03:50 pm EDT
Cabaletta Bio, Inc. announced new clinical and translational data from the first four patients in the lowest dose cohort in RESET-PV evaluating preconditioning-free (PC-free) rese-cel (resecabtagene autoleucel) and initial manufacturing and translational data from the first two autoimmune patients treated with rese-cel manufactured using the automated Cellares Cell Shuttle platform in the RESET clinical development program. A single infusion of the lowest dose of rese-cel administered without preconditioning, after discontinuation of all immunomodulators, demonstrated compelling drug-free responses for 6 months in 2 of 4 refractory patients; next dose cohort actively enrolling. Translational data from the first two patients dosed with rese-cel manufactured on the automated Cell Shuttle platform showed pharmacokinetic and pharmacodynamic data consistent with other patients dosed in the RESET clinical program.
Cabaletta is presenting clinical and translational data from the first four patients with pemphigus vulgaris treated at the lowest dose of rese-cel without preconditioning. As of April 2, 2026, all four patients had been dosed and completed at least 24 weeks of follow-up. The PDAI Total Activity (PDAI) scores ranged from 22 to 83 at baseline.
Key findings from the poster include: Translational Profile: PC-free rese-cel demonstrated similar CAR T cell expansion kinetics relative to reported translational data from RESET patients with preconditioning. In all four patients, the magnitude and timing of rese-cel expansion was consistent with RESET patients with preconditioning. Three of the four patients experienced complete peripheral B cell depletion.
B cell activating factor serum levels, which may correlate with depth of B cell depletion, were increased and reached the lower end of the range achieved in RESET patients with preconditioning. In the three patients with complete peripheral B cell depletion, repopulated B cells reflected an expected transitional naïve phenotype. Safety Profile: Rese-cel was generally well tolerated with no dose-limiting toxicities (DLT) or immune effector cell-associated neurotoxicity syndrome.
One patient experienced transient fever, or grade 1 cytokine release syndrome (CRS). Clinical Profile: All four patients exhibited initial improvement with clinically meaningful reductions in PDAI total activity scores as early as four weeks. Two of the four patients maintained drug-free compelling clinical responses through 6 months of follow-up.
The three patients who exhibited full B cell depletion exhibited the most robust clinical improvements. Serum levels of anti-DSG3 and anti-DSG1 antibodies were reduced with initial improvement in PDAI total activity scores. The favorable safety observations in all patients and unanticipated, compelling drug-free clinical responses in two of the four patients treated at the lowest PC-free rese-cel dose are supportive of the plan to continue to explore higher doses of PC-free rese-cel in PV and other autoimmune diseases.
PC-free rese-cel data at higher doses from RESET-PV are anticipated in Second Half 2026 and initial data at the lowest rese-cel dose from RESET-SLE are expected in First Half 2026 at the European Alliance of Associations for Rheumatology 2026 Congress, being held from June 3-6, 2026, in London, UK. Cabaletta is presenting data highlighting the initial manufacturing and translational data from the first two autoimmune patients dosed with rese-cel manufactured using the automated Cellares Cell Shuttle platform, representing the first use of the Cell Shuttle in any clinical program. As of May 6, 2026, both patients had been dosed and completed at least 4 weeks of follow-up.
Key findings from the poster include: Manufacturing Profile: The Cell Shuttle process supported end-to-end, closed and automated manufacturing intended to improve reproducibility, scalability and process control while reducing manual complexity. The first two GMP doses of rese-cel manufactured on the Cell Shuttle met all release specifications with on-time delivery. Critical product quality metrics, including purity, CAR expression, viability, vector copy number, and cytotoxic activity, were within the established quality range based on historical clinical manufacturing runs.
Initial Translational Profile: Rese-cel with automated manufacturing demonstrated similar peak expansion and B cell depletion kinetics, both at similar magnitudes and timeframes, relative to its broader reported translational profile across RESET trials.