PHILADELPHIA, PA — Cabaletta Bio, Inc. (Nasdaq: CABA) unveiled promising clinical data from its RESET-Myositis™, RESET-SSc™, and RESET-SLE™ trials evaluating rese-cel (resecabtagene autoleucel), reinforcing its potential to deliver long-lasting, drug-free remission across multiple autoimmune disorders. The findings were presented at the 2025 American College of Rheumatology (ACR) Convergence.
Rese-cel, formerly known as CABA-201, showed encouraging efficacy and safety outcomes in patients with myositis, systemic sclerosis, and lupus. According to Chief Medical Officer Dr. David J. Chang, the therapy demonstrated “durable, drug-free clinical responses” and consistent results through the registrational cohort’s primary endpoint.
In the RESET-Myositis™ trial, all four dermatomyositis and antisynthetase syndrome patients who met key inclusion criteria achieved moderate or major improvement at week 16 without the use of immunomodulators. Cabaletta plans to initiate a registrational cohort for this indication later this quarter, targeting a patient group that currently has limited FDA-approved therapies.
In the RESET-SSc™ study, all patients with at least three months of follow-up achieved meaningful clinical improvement off immunosuppressive treatment, highlighting rese-cel’s potential to “reset” the immune system in systemic sclerosis.
Similarly, early results from RESET-SLE™ showed that most patients achieved remission or significant renal response, with notable reductions in disease activity markers such as anti-dsDNA antibodies. Based on these outcomes, Cabaletta is advancing a new cohort in lupus to evaluate rese-cel without preconditioning — an innovation aimed at improving accessibility for women of childbearing age.
Cabaletta expects to align with the U.S. Food and Drug Administration on the registrational trial designs for lupus and systemic sclerosis later this year, while continuing to expand its research into broader autoimmune applications.
Presentation materials from the ACR Convergence 2025 are available on the Posters & Publications section of Cabaletta Bio’s website.
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