Autolus Therapeutics Presents Longer-Term Follow Up Data from CARLYSLE Trial at the American College of Rheumatology Convergence 2026

The safety evaluation covered 15 patients, while complete renal responses occurred in 6/9 participants followed for at least six months.

Rhea-AI Summary

Autolus Therapeutics (Nasdaq: AUTL) presented longer-term Phase I CARLYSLE results for obe-cel in patients with severe, treatment-resistant systemic lupus erythematosus.

At the August 11, 2026 cutoff, 15 patients had received obe-cel, with adult follow-up extending to 25.5 months. Disease activity scores improved, and DORIS remission criteria were achieved by most participants, including 100% followed for at least six months. Among participants followed for at least six months, complete renal response occurred in 6/9 (66.7%) at any time after infusion; one participant (11.1%) achieved partial renal response, beginning at Month 7. No severe renal flares were observed.

No ICANS neurological toxicity, HLH/IEC-HS inflammatory syndromes or Grade ≥3 cytokine release syndrome occurred. Obe-cel is also being evaluated in the Phase II LUMINA trial for severe, treatment-resistant lupus with active lupus nephritis, using a single 50M dose.

Positive

• Minor pointDORIS remission criteria achieved by most participants, including 100% followed for a minimum of six months.
• Minor pointSLEDAI-2K disease activity scores showed clinically significant improvements despite severe disease activity at baseline.
• Minor pointComplete renal response achieved in 6/9 (66.7%) participants followed for a minimum of six months, at any time after infusion.
• Minor pointPartial renal response achieved by one participant (11.1%), with onset at Month 7.
• Minor pointSafety evaluation in 15 patients found no ICANS neurological toxicity, HLH/IEC-HS inflammatory syndromes or Grade ≥3 cytokine release syndrome.

3 minor points

• Minor pointNo severe renal flares were observed.
• Minor pointCAR T-cell expansion and deep B-cell depletion occurred in all cohorts, followed by predominantly transitional/naïve B-cell reconstitution.
• Minor pointPhase II LUMINA evaluation is ongoing in severe, treatment-resistant lupus with active lupus nephritis, using a single 50M dose.

Negative

• None.

Key Figures

Patient follow-up: Up to 25 months Patients infused: 15 patients DORIS achievement: 100% +2 more

Patient follow-up

Up to 25 months

Adult patients in the ongoing Phase 1 CARLYSLE trial

Patients infused

15 patients

As of August 11, 2026

DORIS achievement

100%

Patients followed for a minimum of six months

Complete renal response

6/9 (66.7%)

Among patients followed for a minimum of six months; achieved at any time post-infusion

Partial renal response

1 participant (11.1%)

Onset at Month 7

Key Terms

car t-cell therapy, sledai-2k, icans

3 terms

car t-cell therapy medical

"a CD19-targeting Chimeric Antigen Receptor (CAR) T-cell Therapy"

Car T-cell therapy is a medical treatment that uses a patient’s own immune cells, modified in a lab to better recognize and attack cancer cells. It is considered a breakthrough because it offers potentially long-lasting effects for certain types of cancer. For investors, its development and approval can signal advances in healthcare innovation and potential growth opportunities in the biotech sector.

sledai-2k medical

"clinically significant improvements in SLEDAI-2K"

SLEDAI‑2K is a standardized scoring system used by doctors and researchers to measure how active systemic lupus erythematosus (SLE) is in a patient at a given time. Think of it as a medical scorecard that tallies symptoms and lab findings; changes in the score are used as clear, comparable evidence in clinical trials and regulatory submissions, so it matters to investors because it helps determine whether a treatment works and thus its commercial and approval prospects.

icans medical

"with no ICANS or HLH/IEC-HS"

ICANS (Immune effector Cell-Associated Neurotoxicity Syndrome) is a range of brain-related side effects that can occur after certain immune-cell cancer therapies, such as CAR-T. Symptoms can include confusion, speech problems, seizures or reduced consciousness, and they are caused by an overactive immune response affecting the brain. Investors care because ICANS can influence patient safety, trial outcomes, regulatory approvals, treatment labeling and adoption, all of which affect a therapy’s commercial prospects and development costs.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• 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 

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Autolus report about renal responses in the CARLYSLE trial?

Complete renal response occurred in 6/9 (66.7%) participants followed for a minimum of six months, at any time after obe-cel infusion. One participant (11.1%) achieved partial renal response beginning at Month 7. No severe renal flares were observed.

Which doses and follow-up periods were included in Autolus's CARLYSLE results?

At the August 11, 2026 cutoff, obe-cel had been given at 50M to eight adults and three adolescents, and at 100M to four adults. Median follow-up was 19.0 months for 50M adults, 12.4 months for 100M adults and 10.1 months for 50M adolescents.

How long did B-cell recovery take in Autolus's CARLYSLE trial?

Median time to B-cell recovery was 7.2 months in the 50M adult cohort, 4.3 months in the 100M adult cohort and 6.0 months in the 50M adolescent cohort. After infusion, all cohorts showed deep B-cell depletion followed by reconstitution with predominantly transitional/naïve B-cell types.