Cabaletta Bio Announces Promising Results for CAR-T in Myositis

On October 26, at the world’s largest gathering of rheumatologists, the American College of Rheumatology, Cabaletta Bio unveiled positive new results that could mark a turning point for autoimmune disease treatment.

The company shared new data from its RESET clinical trials for myositis, lupus, and systemic sclerosis — studies that are testing a groundbreaking CAR-T therapy designed to “reset” the immune system and bring lasting remission without ongoing immune-suppressing drugs.

The therapy, known as rese-cel (formerly known as CABA-201), showed remarkable progress. All myositis patients in the Phase 1/2 trial who met key inclusion criteria exceeded the study’s main goal, achieving major improvement without the use of other medications.

“These early results demonstrate what’s possible when innovative science meets deep commitment to patients,” said Dr. Andrew Heaton, Chief Scientific Officer at Cure JM Foundation. “CAR-T therapy has the potential to transform how we treat autoimmune disease, moving us from lifelong immune suppression toward immune reset and true remission. We’re encouraged by this progress and remain dedicated to accelerating research that brings these breakthroughs to our patients.”

These early findings point to a future where CAR-T cell therapy could deliver lasting, drug-free remission for people living with autoimmune diseases such as juvenile myositis.

Across all RESET trials, 76 patients are now enrolled at 77 clinical sites worldwide. For a list of current trial sites, please visit www.curejm.org/clinicaltrials. Some sites are accepting both juvenile and adult patients, while others are enrolling adult patients only.

¿Preguntas? View a Q&A with Cabaletta Bio aquí or an interview with Dr. Anne Stevens, Cure JM’s Medical Advisory Board, where she discusses CAR-T therapies and their potential for autoimmune diseases, aquí.

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