Autolus' Obe-cel Shows 83% Remission Rate in Early Lupus Study, FDA-Backed Phase 2 Next

Author: Benzinga Newsdesk | October 27, 2025 06:10am

Autolus Therapeutics plc (NASDAQ:AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, 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 (srSLE), will be presented during a poster session at the American College of Rheumatology Convergence 2025.

"Data from the CARLYSLE study shows that obe-cel has the potential to make a meaningful clinical impact in patients with severe refractory SLE who are currently without approved treatment options. We observe durable responses in up to 12 months of follow up and an encouraging safety profile in this difficult to treat patient population. All patients were able to reduce glucocorticosteroids to physiological levels, and responses, including kidney responses, occur early and are durable. The deep depletion of the B-cell lineage seen with obe-cel suggests the possibility of an immune reset and continues to underscore the paradigm shift that CD19 CAR T cell therapy may represent for these patients," said Dr. Maria Leandro, consultant rheumatologist at UCL Hospitals and senior lecturer at University College London. "We are excited to expand on this data set at another upcoming meeting before year-end."

Abstract: 2458

Title: Obecabtagene autoleucel (obe-cel), a CD19-targeting autologous chimeric antigen receptor T-cell therapy (CAR T) with a fast off-rate binding domain, in patients with severe, refractory systemic lupus erythematosus (srSLE): preliminary results from the Phase I CARLYSLE study

Session date and time: Tuesday, October 28, 2025; 10:30am - 12:30pm Central Time

Presenting Author: Maria Leandro, MD

Summary: As of August 21, 2025, six patients with srSLE received the obe-cel target dose of 50x106 (±20%). After a minimum follow-up of 6 months (median follow-up 8.9 months [range 6.0 - 13.8]), obe-cel continues to be well tolerated in all patients, with no dose limiting toxicities (DLTs), immune effector cell-associated neurotoxicity syndrome (ICANS) or Grade ≥2 cytokine release syndrome (CRS). Preliminary efficacy data demonstrated remission in 83.3% (n=5) of patients as measured according to Definition of Remission in SLE (DORIS) and a complete renal response (CRR) in 50% (n=3) 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 ≤5mg/day post obe-cel infusion. Deep B-cell depletion was observed in all patients shortly after infusion and was followed by predominantly naïve B-cell reconstitution, suggesting an obe-cel driven immune reset.

These follow-up data from the ongoing CARLYSLE clinical trial support progressing obe-cel into a planned Phase 2 study in srSLE patients with active lupus nephritis. The Company has aligned with the U.S. Food and Drug Administration (FDA) on the Phase 2 trial design and potential registrational path to approval and continues to anticipate dosing the first patient in the Phase 2 clinical trial before year-end 2025.

"These data suggest the safety profile observed in srSLE patients is consistent with our considerable experience in acute leukemia and, combined with sustained renal remissions observed, forms a strong foundation for the Phase 2 LUMINA trial. Leveraging our established commercial presence and manufacturing capabilities, we believe we are well positioned to potentially be first to market with a CAR T therapy in srSLE," said Dr. Christian Itin, Chief Executive Officer of Autolus.

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