Cabaletta Bio reports positive rese-cel data in autoimmune diseases

Cabaletta Bio Inc. (NASDAQ: CABA) announced clinical data for its investigational cell therapy rese-cel across multiple autoimmune diseases at the European Alliance of Associations for Rheumatology 2026 Congress in London.

In the Phase 1/2 RESET-Myositis study, 83% of dermatomyositis patients achieved moderate-to-major Total Improvement Score responses at 16 weeks after discontinuing immunomodulators. All five patients maintained responses through follow-up periods extending to 1.5 years. The company's first juvenile dermatomyositis patient demonstrated a moderate response maintained through 32 weeks of follow-up.

For systemic sclerosis, 83% of patients achieved revised Composite Response Index in Systemic Sclerosis-25 responses at 36 weeks while off immunomodulators. Patients with interstitial lung disease showed median improvement of 7.5% in forced vital capacity at 36 weeks.

In lupus studies, 75% of patients with 12 months of follow-up achieved Definition of Remission in SLE while remaining off immunomodulators. The company reported that one of two patients treated with preconditioning-free rese-cel experienced deep B cell depletion similar to preconditioned patients who achieved immune reset.

Cabaletta plans to initiate a systemic sclerosis registrational study in the fourth quarter of 2026 with approximately 25 patients. The company expects topline data from its registrational dermatomyositis cohort in mid-2027 and plans to include juvenile dermatomyositis in its second-half 2027 biologics license application submission.

The data encompassed 52 evaluable patients across myositis, lupus and systemic sclerosis indications. Safety profiles showed most patients experienced either no cytokine release syndrome or transient fever, with minimal cases of immune effector cell-associated neurotoxicity syndrome reported.

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