- Data show clinically significant improvements in SLEDAI-2K scores and achievement of DORIS in most patients, despite severe disease activity at baseline
- In 15 patients evaluable for safety, obe-cel was well-tolerated with no ICANS, IEC-HS or Grade ≥3 CRS events observed
LONDON and GAITHERSBURG, Md., Nov. 10, 2026 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies and candidates, today announced longer-term 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), was presented today during a poster session at the American College of Rheumatology (ACR) Convergence 2026.
Dr. Matthias Will, Chief Development Officer of Autolus said, “There is a critical unmet need for treatments that work in severe refractory disease of srSLE and lupus nephritis (LN). In the ongoing Phase 1 CARLYSLE trial, we continue to see deep, durable responses with obe-cel and are particularly encouraged by the continued favorable safety profile, in up to 25 months of follow up in adult patients at the data cutoff. We believe these encouraging data underscore the potential for obe-cel as an important treatment option in autoimmune disease.”
Abstract: 2422875 – Poster Presentation
Title: Obecabtagene autoleucel (obe-cel), a CD19-targeting Chimeric Antigen Receptor (CAR) T-cell Therapy, in Adults and Adolescents with Severe, Refractory Systemic Lupus Erythematosus (srSLE): Findings from the Phase I CARLYSLE Study
Session: Poster Session C (2192-2227) Systemic Lupus Erythematosus
Session date and time: Tuesday, November 10; 10:30 AM–12:30 PM ET
Summary: The poster presents safety and efficacy results from the Phase I CARLYSLE study with up to 25 months follow-up in adult patients. As of August 11, 2026, 15 patients were infused with obe-cel at a dose of 50M (8 adults, 3 adolescents) or 100M (4 adults). Median follow-up [range] in the adult 50M, adult 100M, and adolescent 50M cohorts was 19.0 [1.0–25.5] months, 12.4 [3.3–16.4] months, and 10.1 [8.5–11.5] months, respectively. All patients had evidence of active srSLE and 66.7% had class III or IV LN, with or without class V. Obe-cel was well tolerated in adult and adolescent participants with srSLE, with no ICANS or HLH/IEC-HS, and no high-grade CRS events. Response data showed clinically significant improvements in SLEDAI-2K and achievement of DORIS in most participants, including 100% of patients followed for a minimum of six months, despite severe disease activity at baseline. In patients followed for a minimum of six months, complete renal response (CRR) was achieved in 6/9 (66.7%) participants at any time post obe-cel infusion. One participant (11.1%) achieved partial renal response (PRR) with onset at Month 7. No severe renal flares were observed. Robust CAR T-cell expansion and deep B-cell depletion were observed in all cohorts after infusion and participants showed reconstitution with predominantly transitional/naïve B-cell phenotypes. Median time to B-cell recovery was 7.2 months in 50M adult, 4.3 months in 100M adult and 6.0 months in 50M adolescent cohorts.
Obe-cel is being evaluated in the Phase II LUMINA trial in participants with srSLE with active LN, using a single flat dose of obe-cel at 50×10⁶ (50M).
About Autolus Therapeutics plc
Autolus Therapeutics plc (Nasdaq: AUTL) is a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation T cell therapies and candidates for the treatment of cancer and autoimmune disease. Using a broad suite of proprietary and modular T cell programming technologies, Autolus is engineering precisely targeted and controlled T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and eliminate these cells. Autolus has a marketed therapy and a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumors and autoimmune diseases. For more information, please visit www.autolus.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as “may,” “will,” “could,” “expects,” “plans,” “anticipates,” and “believes.” These statements include, but are not limited to, statements regarding Autolus’ future expectations, plans and prospects, including the therapeutic potential and expected clinical benefits of obe-cel; in SLE and LN; the development of obe-cel in autoimmune indications and of additional product candidates, including statements regarding the initiation, timing, progress and results of clinical studies or trials and related preparatory work; expectations regarding regulatory interactions, regulatory pathways and potential accelerated approval pathways; and the period during which the results of clinical studies or trials will become available. Any forward-looking statements are based on management’s current views and assumptions and involve risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks identified in the section titled “Risk Factors” in Autolus’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC), on March 26, 2026 and its subsequent Quarterly Reports on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Autolus’ subsequent filings with the SEC. All information in this press release is as of the date of the release, and Autolus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing Autolus’ views as of any date subsequent to the date of this press release.
Contact:
Amanda Cray
+1 617-967-0207
a.cray@autolus.com
