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Cabaletta Bio Presents New Rese-cel Phase 1/2 Clinical Data at ACR Convergence 2026 Featuring Immunomodulator-Free Durability and Favorable Benefit-Risk Profile Across Autoimmune Diseases

  • 100% (6 of 6) dermatomyositis patients maintained immunomodulator-free moderate-to-major Total Improvement Score responses through one year, with most patients also free of steroids.
  • 100% (5 of 5) lupus nephritis patients with follow-up from six months to two years achieved immunomodulator-free DORIS remission with evidence of little-to-no disease activity on repeat kidney biopsies.
  • 71% (5 of 7) systemic sclerosis patients achieved immunomodulator-free rCRISS-50 responses, while five patients with interstitial lung disease achieved a 9% mean forced vital capacity improvement at one year.
  • A 71-patient clinical experience with resecabtagene autoleucel following preconditioning reinforces a favorable benefit-risk profile across myositis, systemic sclerosis, lupus, & myasthenia gravis.
  • Cabaletta Bio announced new Phase 1/2 clinical data on resecabtagene autoleucel to be presented at the American College of Rheumatology Convergence 2026 annual meeting in Orlando, FL.
  • Nearly all patients discontinued immunomodulators & required no or only low-dose steroids while achieving durable improvement in disease activity as of the September 4, 2026 data cut-off.
  • Cabaletta anticipates reporting topline results from the registrational adult dermatomyositis/antisynthetase syndrome cohort in the second half of 2027.
  • The company plans to submit a Biologics License Application for resecabtagene autoleucel in myositis in the first quarter of 2028.
  • Safety data from 71 patients showed 94% experienced no or Grade 1 cytokine release syndrome, 96% experienced no immune effector cell-associated neurotoxicity syndrome, & no immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome was reported.
  • Cabaletta is enrolling a registrational systemic sclerosis cohort with a focus on interstitial lung disease due to high unmet need & mortality rates in the condition.
Company
Cabaletta Bio
Keywords
Nasdaq:CABA, Cabaletta Bio