Cabaletta Bio, Inc. ((CABA)) announced an update on their ongoing clinical study.
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RESET-MG is a clinical study conducted by Cabaletta Bio, Inc. aimed at evaluating the safety and efficacy of CABA-201, an investigational cell therapy, in participants with generalized Myasthenia Gravis (gMG). This Phase 1/2 open-label study seeks to address the lack of curative treatments for this rare autoimmune disorder, which affects neuromuscular transmission and causes muscle weakness.
The intervention being tested is CABA-201, a biological treatment administered as a single intravenous infusion. It is given following preconditioning with cyclophosphamide and fludarabine, targeting the autoantibody responses in gMG patients.
The study employs an interventional design with a single-group model, focusing on treatment as its primary purpose. There is no masking involved, allowing for an open-label approach to assess the therapy’s effects.
The study began on December 17, 2024, with the latest update submitted on July 15, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates for stakeholders.
For investors, this study represents a significant development in Cabaletta Bio’s portfolio, potentially influencing stock performance positively if successful. The ongoing recruitment and updates may enhance investor confidence, especially in the competitive landscape of autoimmune disorder treatments.
The study is currently recruiting, with further details available on the ClinicalTrials portal.