Autolus Therapeutics Presents Updated Clinical Data from the CARLYSLE Trial in Patients with Severe Refractory Systemic Lupus Erythematosus at the American Society of Hematology (ASH) Annual Meeting 2025

Core Insights - Autolus Therapeutics plc has presented preliminary data from the Phase 1 CARLYSLE trial for its CD19-targeting CAR T-cell therapy, obe-cel, in patients with severe refractory systemic lupus erythematosus (srSLE) at the American Society of Hematology Annual Meeting [1][2] Group 1: Trial Data and Efficacy - The CARLYSLE trial shows a high rate of DORIS responses and a significant reset in the B cell compartment, indicating potential for immune reset in srSLE patients [2][5] - In the 50 million cell dose cohort, 50% of patients achieved complete response rates (CRR) and 83% achieved DORIS, with a median onset of 5.1 months and no new disease activity observed at a median follow-up of 12 months [5][6] - The 100 million cell cohort data is consistent with the 50 million cohort, supporting the progression of obe-cel as a treatment for srSLE, with the 50 million dose selected for the Phase 2 trial [6][7] Group 2: Safety Profile - Obe-cel was well tolerated, with no dose-limiting toxicities or cases of immune effector cell-associated neurotoxicity syndrome (ICANS) observed at the 50 million dose [4][7] - Grade one cytokine release syndrome (CRS) occurred in three patients at both the 50 million and 100 million doses, while transient Grade three liver toxicity was noted in one patient from the 100 million cohort [4][5] - The safety profile of obe-cel is supported by a robust database from previous clinical trials in other indications, indicating deep and durable responses [7][8] Group 3: Future Developments - Autolus has initiated the LUMINA trial, a Phase 2 trial in lupus nephritis with registrational intent, based on the positive initial experience from the CARLYSLE trial [2][6] - The company has aligned with the U.S. Food and Drug Administration (FDA) on the Phase 2 trial design and potential path to approval [6][8] - Autolus is positioned for a successful entry into the autoimmune disease market, leveraging its existing clinical data and manufacturing capabilities [8]