Autolus Therapeutics presents clinical data from CARLYSLE trial

Autolus Therapeutics (AUTL) announces that follow-up data from the ongoing CARLYSLE trial, a Phase 1 dose confirmation clinical trial of obe-cel in severe refractory systemic lupus erythematosus, will be presented during a poster session at the American College of Rheumatology Convergence 2025. As of August 21, 2025, six patients with srSLE received the obe-cel target dose of 50×106. After a minimum follow-up of 6 months, obe-cel continues to be well tolerated in all patients, with no dose limiting toxicities, immune effector cell-associated neurotoxicity syndrome or Grade greater than or equal to2 cytokine release syndrome. Preliminary efficacy data demonstrated remission in 83.3% of patients as measured according to Definition of Remission in SLE and a complete renal response in 50% of patients, without evidence of new disease activity at last follow-up visit. At months six, the SLEDAI-2K score improved in 5/6 patients by a more than 10 point reduction and the kidney component of SLEDAI-2K resolved in the same 5/6 patients, with all non-renal manifestations completely resolved by month four. SLEDAI-2K score reduction and clinical benefit were observed in all patients. Additionally, all patients achieved steroid tapering to less than or equal to5mg/day post obe-cel infusion. Deep B-cell depletion was observed in all patients shortly after infusion and was followed by predominantly naive B-cell reconstitution, suggesting an obe-cel driven immune reset.