Cabaletta Bio (Nasdaq: CABA) reported early clinical data for rese-cel (resecabtagene autoleucel) administered without preconditioning in pemphigus vulgaris, with interim findings from four patients at the lowest dose cohort showing drug-free clinical responses in two of four patients through six months of follow-up, the company said at the ASGCT 2026 Annual Meeting in Boston.
In the RESET-PV Phase I/II trial (NCT04422912), all four patients had been dosed and completed at least 24 weeks of follow-up as of April 2, 2026, with baseline Pemphigus Disease Area Index (PDAI) Total Activity scores ranging from 22 to 83. All four patients exhibited clinically meaningful reductions in PDAI scores by week four. Three of the four patients achieved complete peripheral B-cell depletion, and those three patients showed the most pronounced clinical improvements; the two patients who maintained drug-free responses through six months were among this group. Serum levels of anti-DSG3 and anti-DSG1 antibodies declined in parallel with PDAI improvements. On safety, rese-cel was generally well tolerated at this dose level, with no dose-limiting toxicities and no immune effector cell-associated neurotoxicity syndrome reported; one patient experienced transient fever classified as grade 1 cytokine release syndrome.
The RESET-PV study is an open-label, Phase I/II dose-escalation trial enrolling patients with active pemphigus vulgaris, with a planned enrollment of 40 patients across multiple dose cohorts. The data presented at ASGCT 2026 reflect only the first four patients treated at the lowest preconditioning-free dose — the same dose used across the broader RESET program with preconditioning — and the results remain early and descriptive. The company did not disclose the trial's primary endpoint, and no formal statistical analysis was reported for this cohort. The next dose cohort is actively enrolling, with higher-dose preconditioning-free data from RESET-PV anticipated in the second half of 2026.