Autolus(US:AUTL) Globenewswire·2025-10-27 11:00Core Insights - Autolus Therapeutics plc is advancing its CD19-targeting CAR T cell therapy, obe-cel, for severe refractory systemic lupus erythematosus (srSLE) based on promising data from the CARLYSLE Phase 1 trial [1][4][6] Group 1: Clinical Trial Results - The CARLYSLE trial demonstrated that obe-cel is well tolerated with no dose limiting toxicities, ICANS, or high-grade CRS observed in patients [3][6] - Preliminary efficacy results showed an 83.3% remission rate in patients, with a complete renal response in 50% of patients, and significant improvements in SLEDAI-2K scores [3][6] - All patients were able to taper glucocorticosteroids to physiological levels post-treatment, indicating a potential immune reset due to deep B-cell depletion [2][3] Group 2: Future Development Plans - The company plans to progress obe-cel into a Phase 2 study targeting srSLE patients with active lupus nephritis, having aligned with the FDA on trial design [4][5] - The first patient in the Phase 2 trial is expected to be dosed before the end of 2025 [4][6] Group 3: Company Overview - Autolus Therapeutics is focused on developing next-generation T cell therapies for cancer and autoimmune diseases, leveraging proprietary T cell programming technologies [7] - The company has a marketed therapy, AUCATZYL, which was approved by the FDA for treating relapsed or refractory B-cell precursor acute lymphoblastic leukemia [8]