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Allogene Therapeutics Reports First Clinical Data from Phase 1 RESOLUTION Study of ALLO-329 in Autoimmune Disease

ALLO
  • Allogene Therapeutics announced preliminary safety & efficacy data from the Phase 1 RESOLUTION study of ALLO-329, an investigational allogeneic CAR T product for autoimmune disease.
  • The study evaluated 18 patients with systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or systemic lupus erythematosus (SLE) as of the September 21, 2026 data cutoff.
  • No dose-limiting toxicities (DLTs), immune effector cell-associated hemophagocytic syndrome (IEC-HS), neurotoxicity (ICANS), graft-versus-host disease (GvHD), or Grade ≥3 cytokine release syndrome (CRS) events were observed.
  • Four patients (22%) experienced Grade 1 or 2 CRS, with all treatment-emergent adverse events being Grade 1 or 2 in the no-lymphodepletion cohorts.
  • Eight of 10 patients with skin-predominant SSc achieved & maintained a clinically meaningful improvement of ≥5 points in the modified Rodnan skin score (mRSS).
  • Nine of 10 SSc patients remained off background immunosuppressive therapy, with the longest treatment-free interval exceeding eight months.
  • Clinical improvements were observed across all three lymphodepletion approaches, including no lymphodepletion, at various dose levels starting from Day 14.
  • The study utilized Allogene's proprietary Dagger technology to potentially reduce or eliminate conventional cytotoxic lymphodepletion requirements.
  • Durable clinical improvement occurred without complete peripheral B-cell depletion, suggesting B-cell aplasia may not be necessary to achieve an immune reset.
  • Data will be presented at the 2026 American College of Rheatology (ACR) Convergence following a webinar on November 9, 2026.
  • The RESOLUTION trial continues dose escalation to inform selection of a Phase 2 regimen, with the next data readout planned for 2027.
  • ALLO-329 targets both CD19+ B cells & CD70+ T cells using CRISPR-based site-specific integration for dual CAR expression.
Company
Allogene Therapeutics, Inc.
Keywords
Nasdaq:ALLO, Allogene Therapeutics, Inc., Allogene, allogeneic, autoimmune, CAR T, Cell therapy