Post Body:
Cabaletta Bio is advancing research in multiple sclerosis (MS) with the launch of its RESET-MS clinical trial, a Phase 1/2 study evaluating resecabtagene autoleucel (rese-cel). This CAR T-cell therapy is designed to deplete B-cells.
Rese-cel works by equipping a patient’s T-cells with a receptor targeting the CD19 protein on B-cells. Once infused back into the bloodstream, these engineered cells eliminate B-cells, aiming to reset the immune system and deliver lasting benefits.
“We look forward to building on our momentum as we move closer to realizing our vision of launching the first targeted curative cell therapy designed specifically for patients with autoimmune disease,” said Dr. Steven Nichtberger, CEO of Cabaletta Bio.
The RESET-MS trial will enroll adults aged 18–60 with relapsing or progressive MS. Participants will first receive chemotherapy drugs to prepare their immune systems, followed by a single infusion of rese-cel. Eligibility requirements include a recent history of disease activity for relapsing MS or progressive disability for progressive MS, with exclusions for patients with seizure disorders or recent B-cell-depleting therapy use.
Rese-cel has received FDA fast-track designation, reflecting its potential to address an urgent unmet need. Cabaletta is also exploring rese-cel’s applications in other autoimmune diseases, such as lupus and systemic sclerosis.
