Cabaletta sets 2028 filing target as CAR T data span three autoimmune diseases

Cabaletta Bio has put a timetable on the commercial case for rese-cel, its investigational CD19-directed CAR T. It expects topline results from a registrational study in dermatomyositis and anti-synthetase syndrome in the second half of 2027, and plans to file a Biologics License Application for myositis in the first quarter of 2028. The company laid out the schedule alongside Phase 1/2 data presented on 8 November 2026 at the ACR Convergence meeting.

The efficacy figures come from very small cohorts. All six dermatomyositis patients were still showing moderate-to-major responses on the Total Improvement Score a year after treatment, while off immune-modulating medicines. In lupus nephritis, all five patients who had a biopsy met DORIS remission criteria. In systemic sclerosis, five of seven patients reached rCRISS-50.

Safety data were drawn from a larger pool of 71 patients across the programme. Of these, 94% had either no cytokine release syndrome or only Grade 1 events, and 96% had no immune effector cell-associated neurotoxicity. The company reported no cases of IEC-HS, a haemophagocytic lymphohistiocytosis-like syndrome linked to cell therapies.

The summary provided to CompePharma contains no information on pricing, manufacturing capacity, partnering or reimbursement, so the commercial implications are not yet quantifiable. With cohorts this size, the registrational dermatomyositis and anti-synthetase study is the main test of whether the early signals hold up.