PHILADELPHIA, PA — Cabaletta Bio, Inc. (Nasdaq: CABA) presented initial data from its ongoing RESET-PV™ trial evaluating rese-cel (resecabtagene autoleucel, formerly CABA-201) in patients with pemphigus vulgaris (PV) during the 2025 European Society of Gene & Cell Therapy (ESGCT) Annual Congress, held October 7–10 in Seville, Spain.
The study evaluated rese-cel at 1 x 10⁶ cells/kg without preconditioning in three patients. Results demonstrated complete B cell depletion, rapid reduction in autoantibodies, and near-complete resolution of clinical symptoms in two of the three refractory patients. All three remained off immunomodulators since infusion and were off or tapering steroids as of the September 11, 2025, data cut-off.
Cabaletta reported that CAR T cell expansion in patients treated without preconditioning was similar to levels observed in over 30 patients who received preconditioning across other RESET™ trials, supporting continued exploration of the simplified regimen.
“These 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, we plan to first 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, we are pursuing the incorporation of no preconditioning regimens in certain other RESET clinical trial program cohorts. We look forward to communicating updates on our no preconditioning strategy in PV as well as in other autoimmune indications, along with broader clinical updates from ongoing RESET trials, at upcoming medical meetings.”
The RESET-PV trial is the first within Cabaletta’s RESET program to evaluate rese-cel without the use of cyclophosphamide and fludarabine preconditioning. Because all RESET studies share a consistent single-dose design, the company noted that the data can inform future trials and help determine whether preconditioning may be safely removed in certain indications.
Safety data showed that rese-cel was generally well tolerated. No cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were reported. One patient experienced a mild, transient fever, and another required a brief steroid course for a disease flare that was less severe than prior episodes.
Clinical activity was observed across all three patients, with early improvements in Pemphigus Disease Area Index (PDAI) scores for skin, scalp, and mucosal surfaces. From baseline to latest follow-up, PDAI activity scores improved from 24 to 10, 83 to 3, and 22 to 2. Patients who achieved complete B cell depletion showed the most significant reductions.
Cabaletta stated that additional data and presentation materials from the ESGCT meeting will be made available on the company’s website.
Rese-cel is an investigational autologous CAR-T therapy designed to transiently and deeply deplete CD19-positive B cells with the goal of resetting immune function and achieving durable clinical responses without chronic therapy.
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