CABA Cabaletta Bio

rese-cel · NCT06154252 registry update

countries: {'total_sites': 35, 'us_sites': 31} → {'total_sites': 38, 'us_sites': 31}

Cabaletta Bio: RESET-Myositis registrational data mid-2027, RESET-SSc enrollment 4Q26

The 8-K updates the RESET clinical program: registrational RESET-Myositis DM/ASyS cohort data now guided for mid-2027 to support a 2H27 BLA submission; a new ~25-patient registrational RESET-SSc cohort in SSc-associated ILD is slated to begin enrollment in 4Q26; PC-free dosing is being added to RESET-MG and higher-dose PC-free cohorts are advancing in RESET-PV and RESET-SLE.

Cabaletta Bio presents new rese-cel data at EULAR 2026 Congress

The June 3, 2026 press release discloses updated Phase 1/2 clinical data for rese-cel across myositis, lupus and systemic sclerosis presented at the EULAR 2026 Congress. The data support the registrational strategy in myositis and systemic sclerosis and provide early evidence that the lowest dose of preconditioning-free rese-cel can achieve deep B-cell depletion in lupus. The company also announced plans to initiate a single-arm registrational study in systemic sclerosis-associated ILD in 4Q26 and to include juvenile dermatomyositis in a planned 2H27 BLA submission.

Cabaletta Bio to present complete Phase 1/2 lupus and scleroderma data at EULAR 2026

The company will present complete Phase 1/2 cohort data for rese-cel in SLE and SSc at the June 2026 EULAR Congress. These data will guide selection of the second pivotal indication after the myositis cohort, which is already advancing toward a planned 2027 BLA submission.

Cabaletta Bio April 2026 corporate presentation outlines 2026 data readouts

The April 2026 corporate presentation sets out a 2026 schedule of clinical data readouts for rese-cel, including complete Phase 1/2 data in systemic sclerosis and lupus in 1H26, longer-term PV/SLE data without preconditioning, and initial automated manufacturing data. It also confirms the pivotal myositis study is enrolling with a planned 2027 BLA submission.

Cabaletta Bio: rese-cel myositis BLA submission on track for 2027

The registrational DM/ASyS cohort in RESET-Myositis is now enrolling 17 patients with a 16-week primary endpoint and outpatient dosing option. If successful, data from this cohort will support Cabaletta’s first projected BLA submission for rese-cel in myositis in 2027.

Cabaletta Bio plans 2027 rese-cel BLA submission in myositis

Cabaletta initiated the FDA-aligned myositis registrational cohort in December 2025 and plans to submit the first BLA for rese-cel in 2027. The 17-patient single-arm cohort uses a 16-week primary endpoint of moderate or major total improvement score response off immunomodulators and on no or low-dose steroids. Data from the Phase 1/2 RESET-Myositis trial support the registrational design.

Cabaletta Bio plans 2027 BLA submission for rese-cel in myositis

The company announced alignment with FDA on a 14-patient, single-arm registrational cohort in the RESET-Myositis trial for dermatomyositis/antisynthetase syndrome. All Phase 1/2 patients meeting key criteria achieved the 16-week primary endpoint. Enrollment in the registrational cohort is expected to begin this quarter, supporting a planned BLA submission in 2027.

Cabaletta Bio: FDA-aligned registrational cohort for rese-cel in myositis

FDA alignment achieved in Type C meeting on single-arm 14-patient registrational cohort in DM/ASyS within RESET-Myositis trial. Primary endpoint is moderate or major TIS response at 16 weeks off immunomodulators and on no or low-dose steroids. Registrational cohort to initiate in 4Q25 with BLA submission planned for 2027.

Cabaletta Bio presents positive rese-cel data at ACR Convergence 2025

All DM/ASyS patients meeting registrational criteria achieved moderate or major TIS responses off immunomodulators at week 16. Company is initiating a 14-patient registrational cohort in RESET-Myositis this quarter with a 16-week primary endpoint. RESET-SLE trial is expanding to include a no-preconditioning cohort with initial data expected in 2026.

Cabaletta presents first rese-cel data without preconditioning at ESGCT 2025

Cabaletta presented initial dose data from the RESET-PV trial showing that a single infusion of rese-cel at 1 x 10^6 cells/kg without preconditioning achieved complete B cell depletion and meaningful early clinical responses in three pemphigus vulgaris patients. The company plans to expand enrollment in the RESET-PV trial at the current dose and explore no-preconditioning regimens in other RESET cohorts. All adult Phase 1/2 cohorts in myositis, lupus, scleroderma, and myasthenia gravis RESET trials are fully enrolled as of September 30, 2025.