Nov 9, 6:04 AM ET
Cabaletta Bio Presents Rese-cel Phase 1/2 Data at ACR Convergence 2026 Meeting
Cabaletta Bio released new Phase 1/2 clinical data on its investigational cell therapy rese-cel, presented at the ACR Convergence 2026 meeting, covering dermatomyositis, lupus nephritis, and systemic sclerosis patients followed up to one year. The company reported that 100% (6/6) of dermatomyositis patients maintained immunomodulator-free responses through one year, and it reiterated plans for registrational topline results in the second half of 2027 and a planned BLA submission in the first quarter of 2028. The sample sizes are small, and the filing does not report any financial figures.
- 100% (6/6) of dermatomyositis patients maintained immunomodulator-free, moderate-to-major TIS responses through one year
- 71% (5/7) of systemic sclerosis patients achieved rCRISS-50 at one year; five patients with interstitial lung disease showed 9% mean FVC improvement
- Grade 2 cytokine release syndrome was reported in 6% (4/71) of 71 patients; no IEC-HS was reported
- Registrational topline results expected in 2H 2027; planned BLA submission in myositis in 1Q 2028