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Autolus Therapeutics Presents Longer-Term Follow Up Data from CARLYSLE Trial at the American College of Rheumatology Convergence 2026

  • Longer-term follow-up data from the Phase 1 CARLYSLE trial of obe-cel in severe refractory systemic lupus erythematosus (srSLE) were presented at ACR Convergence 2026.
  • As of August 11, 2026, 15 patients (8 adults 50M dose, 3 adolescents 50M dose, 4 adults 100M dose) received obe-cel infusions.
  • Median follow-up periods were 19.0 months for adult 50M, 12.4 months for adult 100M, 10.1 months for adolescent 50M, with a maximum of 25.5 months.
  • Clinically significant improvements in SLEDAI-2K scores were observed in most patients, along with achievement of DORIS criteria despite severe baseline disease activity.
  • All patients followed for at least six months achieved DORIS response criteria.
  • Complete renal response (CRR) was achieved in 6 of 9 participants (66.7%) with active lupus nephritis, while 1 participant (11.1%) achieved partial renal response at Month 7.
  • No severe renal flares were observed during the study period.
  • The therapy demonstrated a favorable safety profile with no ICANS, HLH/IEC-HS, or Grade ≥3 CRS events in 15 evaluable patients.
  • Robust CAR T-cell expansion 4 deep B-cell depletion occurred post-infusion, followed by B-cell reconstitution with predominantly transitional/naïve phenotypes.
  • Median B-cell recovery times were 7.2 months (50M adult), 4.3 months (100M adult), 4.3 months (100M adult), 6.0 months (50M adolescent).
  • Obe-cel is currently being evaluated in the Phase II LUMINA trial for srSLE with active lupus nephritis using a single flat dose of 50M.
Company
Autolus Inc.
Keywords
Nasdaq:AUTL, Autolus Inc., SLE, carlysle trial, systemic lupus erythematosus, lupus nephritis, obe-cel, Dr Matthias Will