Cabaletta Bio reports phase 1/2 data for autoimmune therapy
Philadelphia - Cabaletta Bio Inc. showcased promising phase 1/2 clinical data for its experimental cell therapy resecabtagene autoleucel at the American College of Rheumatology Convergence 2026 meeting, revealed a September 4 release. The therapy treated 71 patients across four autoimmune conditions as of the data cutoff. In dermatomyositis, all six patients maintained steroid-free Total Improvement Score responses after one year, many of them also stopping steroids by week 52.
For lupus nephritis, five patients achieved DORIS remission without immunomodulators following kidney biopsies. Systemic sclerosis saw five of seven patients reach rCRISS-50 at the one-year mark, and interstitial lung disease patients exhibited a 9% increase in forced vital capacity. Safety data showed 94% of patients experienced no cytokine release syndrome or Grade 1 events, while 6% reported Grade 2 incidents.
No immune effector cell-associated neurotoxicity or hemophagocytic lymphohistiocytosis-like syndrome was observed in 96% of patients. The single infusion therapy, following preconditioning, led to most patients discontinuing immunomodulators and needing minimal steroids. Cabaletta plans to share topline results from its dermatomyositis and antisynthetase syndrome cohort later in 2027 and submit a Biologics License Application for resecabtagene autoleucel in myositis by the first quarter of 2028.
The company is also enrolling a registrational systemic sclerosis cohort, focusing on interstitial lung disease.
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