Autolus Therapeutics (AUTL) presented updated clinical data from its CARLYSLE trial in patients with severe refractory systemic lupus erythematosus at the American Society of Hematology (ASH) Annual Meeting yesterday.
CARLYSLE is an ongoing phase 1 study evaluating the initial safety, preliminary efficacy, pharmacokinetics, and biomarker results of the company's lead drug Obecabtagene autoleucel (Obe-cel) in patients with severe, refractory systemic lupus erythematosus (SLE).
The presentation at the ASH included 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. Nine adult patients were infused with obe-cel, including six at the 50M dose and three at the 100M dose.
Among the six patients who received obe-cel target dose of 50M, half of the patients had a complete renal response, and five out of six (83%) reached remission as measured according to Definition of Remission in SLE (DORIS) criteria.
Evaluation is in progress for the 100 million M cohort group, with initial data suggesting substantial early improvement in three patients dosed with 100 million cells.
The CARLYSLE trial findings support moving obe-cel forward for severe refractory lupus, with 50M chosen as the recommended Phase 2 dose. A phase 2 trial of obe-cel in severe refractory systemic lupus erythematosus, dubbed LUMINA, is now enrolling.
Obecabtagene autoleucel or obe-cel is a B-lymphocyte antigen CD19 (CD19) chimeric antigen receptor (CAR) T cell therapy. It was approved by the FDA for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia on November 8, 2024, and was granted conditional marketing authorization by MHRA in the UK and EMA in the EU in 2025 and is marketed under the brand name AUCATZYL.
AUCATZYL generated net product revenue of $51 million in the first nine months of 2025.
AUTL closed Monday's trading at $1.59, up 2.58%. In premarket trading Tuesday, the stock is down 2.5% at $1.55.
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