Cabaletta presents one-year rese-cel data at ACR, details durability across four autoimmune diseases
New Phase 1/2 results show immunomodulator-free responses sustained at one year in dermatomyositis, lupus nephritis and systemic sclerosis, with a favorable safety profile across 71 patients.
Cabaletta Bio presented new Phase 1/2 clinical data on resecabtagene autoleucel (rese-cel) at the American College of Rheumatology Convergence 2026 meeting in Orlando, in one oral and two poster presentations, with a data cut-off of September 4, 2026, according to an 8-K filed November 9, 2026.
In dermatomyositis, 100% (6/6) of patients maintained an immunomodulator-free, moderate-to-major Total Improvement Score response through one year, with 83% (5/6) achieving that level as early as Week 16, the timepoint corresponding to the primary endpoint of the ongoing registrational cohort.1 Most of these patients were also free of steroids at Week 52.1
In lupus nephritis, 100% (5/5) of patients who underwent an optional repeat kidney biopsy after rese-cel infusion achieved DORIS remission off all immunomodulators and on no or low-dose steroids, and all five demonstrated histologic response or remission.1
In systemic sclerosis, 71% (5/7) of patients achieved rCRISS-50 at one year, with 86% (6/7) achieving rCRISS-25, and the five patients with interstitial lung disease showed a 9% improvement in mean percent-predicted FVC at one year.1
Across the broader 71-patient safety dataset spanning four autoimmune diseases, 94% (67/71) of patients experienced no or Grade 1 cytokine release syndrome, with Grade 2 CRS reported in 6% (4/71).1 96% (68/71) experienced no immune effector cell-associated neurotoxicity syndrome, and no immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome was reported.1
The company reaffirmed prior guidance: Cabaletta anticipates reporting topline results from the registrational adult DM/ASyS cohort in the second half of 2027 and submitting a BLA for rese-cel in myositis, including adult DM and all available juvenile DM Phase 1/2 data, in the first quarter of 2028.1 In systemic sclerosis, Cabaletta is enrolling a registrational cohort with a focus on interstitial lung disease, citing high unmet need and one of the highest mortality rates among rheumatological conditions.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.