PHILADELPHIA, October 9, 2025 — Leads & Copy — Cabaletta Bio, Inc. (Nasdaq: CABA) presented initial data from the RESET-PV™ trial evaluating rese-cel (resecabtagene autoleucel, formerly known as CABA-201) at 1 x 106 cells/kg without preconditioning in three evaluable patients with pemphigus vulgaris (PV). The data were presented at the 2025 European Society of Gene & Cell Therapy (ESGCT) Annual Congress in Seville, Spain.
The data provide preliminary evidence that a single infusion of rese-cel without preconditioning can achieve complete B cell depletion and meaningful early clinical responses with a simplified regimen that can expand access to patients who may desire a treatment option without preconditioning, said David J. Chang, M.D., Chief Medical Officer of Cabaletta. Based on the observed biologic activity and early clinical responses, the company plans to expand patient enrollment in the RESET-PV trial at the current dose and potentially evaluate higher doses of rese-cel in PV patients, as warranted. In addition, Cabaletta is pursuing the incorporation of no preconditioning regimens in certain other RESET clinical trial program cohorts.
Key clinical and translational insights from the follow-up of the patients highlighted as of the data cut-off date of September 11, 2025, include Rese-cel exhibited similar CAR T cell expansion and contraction kinetics relative to translational data reported from other RESET trials with preconditioning. All three patients experienced substantial depletion of B cells within the first month post-infusion, with patients 2 and 3 achieving complete peripheral B cell depletion.
Rese-cel was generally well tolerated with no immune effector cell-associated neurotoxicity syndrome (ICANS) reported. Meaningful early clinical responses were observed in all three patients starting in the first month post-infusion based on Pemphigus Disease Area Index (PDAI) score for skin, scalp and mucosal surfaces. All three patients remain off immunomodulators as of the data cut-off.
Additional information can be accessed on the website of the 2025 ESGCT Annual Congress. The Company has made available the accepted abstract and will make available oral presentation materials following their presentation on the Posters & Publications section of its website.
Rese-cel is an investigational, autologous CAR-T cell therapy engineered with a fully human CD19 binder and a 4-1BB co-stimulatory domain, designed specifically for the treatment of autoimmune diseases. Cabaletta is evaluating rese-cel in the RESET (REstoring SElf-Tolerance) clinical development program.
Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases.
Contact: Anup Marda, Chief Financial Officer, investors@cabalettabio.com
Source: Cabaletta Bio
