On December 8, 2025 Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, reported presentation of preliminary data from the ongoing Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus (srSLE) in an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

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Dr. Matthias Will, Chief Development Officer of Autolus, said: "Patients with srSLE have limited remaining treatment options and represent a difficult to treat population with a critical unmet need. Data reported from the CARLYSLE trial show an encouraging high rate of DORIS responses and a deep reset in the B cell compartment induced by obe-cel, suggesting the possibility for an immune reset. Based on this positive initial experience with obe-cel in the CARLSYLE trial we have initiated the LUMINA trial, a Phase 2 trial in lupus nephritis with registrational intent."

Abstract 302
Title: Obecabtagene autoleucel (obe-cel), a CD19-targeting chimeric antigen receptor (CAR) T-cell therapy, in patients with severe, refractory systemic lupus erythematosus (SLE) in the Phase I CARLYSLE study: initial safety, preliminary efficacy, pharmacokinetics, and biomarker results
Session Name: Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Emerging CAR-T Cell Therapies for Acute Leukemias and Autoimmune Diseases
Session Date and Time: December 8, 2025; 11:30 – 11:45am ET
Session Room: Orange County Convention Center; Valencia Room W415D
Publication Number: 815
Presenting Author: Claire Roddie, MD, PhD, FRCPath, Associate Professor Haematology and Honorary Consultant Haematologist, Cancer Institute, University College London (UCL)

Summary: Updated Phase 1 data with longer follow-up, and data in patients who received both 50×106 (50M) and 100×106 (100M) CAR T-cells were presented. Nine adult patients were infused with obe-cel, including six at the 50M dose and three at the 100M dose.

Obe-cel was well tolerated in all patients. No dose limiting toxicities (DLTs) or cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were observed at the 50M dose. Grade one cytokine release syndrome (CRS) was observed in three patients at the 50M dose and three patients at the 100M dose. Hypertension was observed in five patients at the 50M dose, with three of those patients having pre-existing history of hypertension. A case of transient Grade three liver toxicity was observed in one patient of the 100M cohort.

At the 50M dose, three patients (50%) achieved CRR and five patients (83%) achieved DORIS with a median onset of 5.1 months (range: 4.9–8.9), without evidence of new disease activity at a median of 12 months of follow up (range: 8.5–16.3). All non-renal manifestations of the disease resolved by month four. Urinary protein creatinine (UPC) ratio levels decreased over time, demonstrating significant decline or absence of disease activity. Data show high peak expansion and deep B cell aplasia consistent with known obe-cel characteristics in oncology indications. Peak expansion was reached at a median of 10 days (range: 9–13). The median time to loss of CAR T-cell persistence based on Kaplan-Meier analysis was 3.0 months. The B-cell reconstitution profiles suggest that obe-cel may induce a reset of pathologic autoimmunity.

Emerging data in the 100M cohort is consistent with the 50M adult cohort, and evaluation is ongoing.

Data support progressing obe-cel as a treatment for srSLE and 50M has been selected as the recommended Phase 2 dose. Autolus has aligned with U.S. Food and Drug Administration (FDA) on a Phase 2 trial design in LN and potential registrational path to approval. The LUMINA trial is now enrolling.

Dr. Christian Itin, Autolus Chief Executive Officer, said: "Obe-cel’s safety profile is based on a robust database spanning several clinical trials in B-ALL and B-NHL indications. Data presented today now also show the ability to induce deep depletion of B-cell lineages in patients with srSLE. Obe-cel successfully underwent the regulatory approval process with the FDA, EMA and MHRA in adult r/r B-ALL and launched commercially in the US and UK in 2025. Building on this strong foundation of clinical data, and demonstrated commercial and manufacturing capabilities, we believe Autolus is well positioned for a successful and efficient path into the autoimmune setting."

(Press release, Autolus, DEC 8, 2025, View Source [SID1234661278])