Resecabtagene autoleucel (rese-cel, formerly referred to as CABA-201) - (RESET-PV)

March 23, 2026: Cabaletta Bio, Inc. (NASDAQ: CABA) provided a business update for rese-cel (resecabtagene autoleucel), an investigational autologous CD19 CAR T therapy for autoimmune diseases, alongside FY2025 results.

• RESET-Myositis (dermatomyositis/antisynthetase syndrome): A 17-patient, single-arm registrational cohort is enrolling, including an outpatient dosing option. Primary endpoint is a 16-week moderate/major total improvement score response while off immunomodulators and on no/low-dose steroids. If successful, the company projects its first BLA submission for rese-cel in myositis in 2027.

• Automated manufacturing (Cellares Cell Shuttle): Initial clinical experience with Cellares-manufactured rese-cel is expected in 1H26 to confirm GMP readiness and logistics; longer-term clinical data are expected in 2H26.

• No-preconditioning program: Initial no-preconditioning data from RESET-SLE are expected in 1H26, with durability data in 2H26. Dose-ranging durability data from RESET-PV are anticipated throughout 2026.

• Upcoming data/presentations: Complete Phase 1/2 data from RESET-SLE, RESET-SSc, and RESET-MG are expected in 1H26; RESET-MG will be presented April 20, 2026 at the AAN Annual Meeting. The company plans a RESET-SSc registrational design update in 1H26 and a RESET-MG registrational design update in mid-2026.