PHILADELPHIA, PA — Cabaletta Bio, Inc. (Nasdaq: CABA) reported early clinical data showing two of four autoimmune disease patients treated with its experimental CAR-T therapy remained drug-free for six months without preconditioning treatment, a development the company says could expand outpatient use of the therapy.
The data, presented at the American Society of Gene & Cell Therapy annual meeting in Boston, came from the first four patients enrolled in the lowest-dose cohort of the company’s RESET-PV trial evaluating rese-cel, or resecabtagene autoleucel, in patients with refractory pemphigus vulgaris.
Cabaletta said the therapy was administered without preconditioning chemotherapy and after discontinuation of immunomodulator drugs.
“Fifty percent of the patients demonstrated compelling and drug-free responses through 6 months of follow-up,” Chief Medical Officer David Chang stated, adding that preconditioning-free treatment “has the potential to substantially expand access for patients in current CAR T centers on an outpatient basis as well as in community-based infusion centers.”
The company said all four patients experienced clinically meaningful reductions in disease activity scores within four weeks of treatment. Three patients achieved complete peripheral B-cell depletion, which Cabaletta said corresponded with the strongest clinical responses.
The treatment was generally well tolerated, according to the company. No dose-limiting toxicities or neurotoxicity events were reported. One patient experienced grade 1 cytokine release syndrome involving transient fever.
Cabaletta also released initial manufacturing and translational data from the first two autoimmune disease patients treated with rese-cel produced using the automated Cellares Cell Shuttle manufacturing platform.
The company said the automated process produced therapies meeting all release specifications and demonstrated pharmacokinetic and pharmacodynamic profiles consistent with previous RESET program patients.
Chang said the manufacturing data could support a scalable commercial supply process if the therapy receives regulatory approval.
“We believe this is central to being able to meet the potential demand for rese-cel from thousands of patients living with autoimmune diseases,” he stated.
Cabaletta said higher-dose preconditioning-free data from RESET-PV are expected in the second half of 2026. Initial data from the RESET-SLE lupus study are expected during the first half of 2026 at the European Alliance of Associations for Rheumatology Congress in London.
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