Cabaletta Bio’s RESET-MS Study: A New Frontier in Multiple Sclerosis Treatment

Cabaletta Bio, Inc. ((CABA)) announced an update on their ongoing clinical study.

RESET-MS is a Phase 1/2 open-label study conducted by Cabaletta Bio, Inc., aimed at evaluating the safety and efficacy of CABA-201, an autologous CD19-specific chimeric antigen receptor T cell therapy, in participants with multiple sclerosis (MS). The study focuses on both relapsing and progressive forms of MS, seeking to address the unmet needs in treatment options for these conditions.

The intervention being tested is CABA-201, a biological treatment administered as a single intravenous infusion following preconditioning with fludarabine and cyclophosphamide. This approach targets CD19, a protein found on the surface of certain immune cells, aiming to modulate the immune response in MS patients.

The study is designed as an interventional, non-randomized, sequential trial with no masking, primarily focused on treatment. It involves two experimental cohorts: one for relapsing MS and another for progressive MS, both receiving the same biological intervention.

The study is not yet recruiting, with key dates including a study start date of April 22, 2025, and the last update on May 27, 2025. These dates are crucial for tracking the study’s progress and anticipating future developments.

The update on this study could influence Cabaletta Bio’s stock performance and investor sentiment, as successful outcomes may enhance the company’s position in the competitive MS treatment market. Investors should monitor this study’s progress, as it could signal significant advancements in MS therapies.

The RESET-MS study is ongoing, with further details available on the ClinicalTrials portal.