Clinical trialsCompany release

Cabaletta's rese-cel CAR T keeps myositis responses at one year without immunomodulators

🇺🇸 Cabaletta Bio, Inc. (CABA) · Mon 09 Nov 2026

Phase 1/2 data at ACR Convergence 2026 show durable responses across myositis, lupus nephritis and systemic sclerosis, with a low rate of severe cytokine release syndrome.

Cabaletta Bio presented new Phase 1/2 results for rese-cel, its investigational CD19 CAR T therapy, at the ACR Convergence 2026 meeting on 8 November 2026. The data cover patients with myositis, lupus nephritis and systemic sclerosis (scleroderma).

In dermatomyositis, all six patients maintained moderate-to-major responses on the Total Improvement Score (TIS) at one year, without immunomodulatory drugs. In lupus nephritis, all five patients who underwent biopsy reached DORIS remission. In systemic sclerosis, five of seven patients achieved rCRISS-50.

On safety, the company reported results across 71 patients. In that group, 94% had either no cytokine release syndrome (CRS) or Grade 1 CRS, and 96% had no immune effector cell-associated neurotoxicity syndrome (ICANS). No cases of immune effector cell-associated haemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) were reported.

Cabaletta expects topline data from its registrational study in dermatomyositis and anti-synthetase syndrome (DM/ASyS) in the second half of 2027. It plans to submit a Biologics License Application (BLA) for myositis in the first quarter of 2028.

What it means for your team

  • Registrational DM/ASyS topline data (2H 2027) and a myositis BLA submission (Q1 2028) set the timetable for regulatory planning on this programme.
  • The reported CRS, ICANS and IEC-HS rates will be a reference point for safety monitoring and risk-management planning for CAR T use in autoimmune disease.
  • The group sizes are small (six dermatomyositis, five biopsied lupus nephritis, seven systemic sclerosis patients), so the efficacy findings remain early-stage and the registrational study will be the key test.
  • Payers and market-access teams may watch the immunomodulator-free responses as a possible marker of treatment value, though no pricing or access information has been provided.

Company's press release (SEC filing): Cabaletta Bio, Inc. ↗

Article written by VigiEye from the official source (Cabaletta Bio, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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