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Autolus Therapeutics to Present Clinical Data Update at the American College of Rheumatology (ACR) Convergence 2025

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Autolus Therapeutics (Nasdaq: AUTL) has announced it will present updated clinical data from its CARLYSLE study at the upcoming American College of Rheumatology (ACR) Convergence 2025, scheduled for October 24-29 in Chicago.

The presentation will focus on obecabtagene autoleucel (obe-cel), a CD19-targeting CAR T-cell therapy, in treating patients with severe refractory systemic lupus erythematosus (srSLE). Initial findings demonstrate a favorable safety profile with no dose limiting toxicities, no ICANS, and no Grade ≥2 cytokine release syndrome. The study showed SLEDAI-2K score improvements and clinical benefits across all patients, with three patients achieving complete renal response.

Autolus Therapeutics (Nasdaq: AUTL) ha annunciato che presenterà dati clinici aggiornati dallo studio CARLYSLE al prossimo American College of Rheumatology (ACR) Convergence 2025, in programma dal 24 al 29 ottobre a Chicago.

La presentazione si focalizzerà su obecabtagene autoleucel (obe-cel), una terapia con CAR T-cell mirata al CD19, nel trattamento di pazienti con lupus eritematoso sistemico grave resistente (srSLE). I risultati iniziali mostrano un profilo di sicurezza favorevole con nessuna tossicità dose-limitante, nessun ICANS e nessun sindrome da rilascio di citochine di grado ≥2. Lo studio ha evidenziato miglioramenti del punteggio SLEDAI-2K e benefici clinici in tutti i pazienti, con tre soggetti che hanno raggiunto una risposta renale completa.

Autolus Therapeutics (Nasdaq: AUTL) ha anunciado que presentará datos clínicos actualizados del estudio CARLYSLE en el próximo Convergence 2025 de la American College of Rheumatology (ACR), que se celebrará del 24 al 29 de octubre en Chicago.

La presentación se centrará en obecabtagene autoleucel (obe-cel), una terapia de CAR T células dirigida al CD19, para tratar a pacientes con lupus eritematoso sistémico grave refractario (srSLE). Los hallazgos iniciales muestran un perfil de seguridad favorable con ninguna toxicidad dosis-limitante, sin ICANS y sin síndrome de liberación de citocinas de grado ≥2. El estudio mostró mejoras en el puntaje SLEDAI-2K y beneficios clínicos en todos los pacientes, con tres pacientes alcanzando una respuesta renal completa.

Autolus Therapeutics (Nasdaq: AUTL)가 CARLYSLE 연구의 업데이트 데이터를 ACR Convergence 2025에서 발표할 예정이라고 발표했습니다. 행사는 시카고에서 10월 24-29일로 예정되어 있습니다.

발표는 CD19를 표적으로 하는 CAR T 세포 치료제 obecabtagene autoleucel (obe-cel)에 초점을 맞추고, 중증 난치성 전신 홍반 루푸스(SrSLE) 환자 치료에 관한 내용입니다. 초기 소견은 용량 제한 독성 없음, ICANS 없음, 등급 ≥2의 사이토카인 방출 증후군 없음 등 안전성 프로파일이 유리함을 보여줍니다. 연구는 SLEDAI-2K 점수의 개선과 모든 환자에서 임상적 이익을 보였으며, 3명의 환자가 신장 반응을 완전히 달성했습니다.

Autolus Therapeutics (Nasdaq: AUTL) a annoncé qu'il présentera des données cliniques mises à jour de l'étude CARLYSLE lors de la prochaine convergence de l'American College of Rheumatology (ACR) 2025, qui se déroulera du 24 au 29 octobre à Chicago.

La présentation portera sur obecabtagene autoleucel (obe-cel), une thérapie par CAR T ciblant le CD19, dans le traitement des patients atteints de système lupus érythémateux grave réfractaire (srSLE). Les résultats préliminaires montrent un profil de sécurité favorable avec aucune toxicité limitant la dose, pas d'ICANS et pas de syndrome de libération de cytokines de grade ≥2. L'étude a montré des améliorations du score SLEDAI-2K et des bénéfices cliniques chez tous les patients, trois patients ayant atteint une réponse rénale complète.

Autolus Therapeutics (Nasdaq: AUTL) hat angekündigt, aktualisierte klinische Daten aus der CARLYSLE-Studie auf dem bevorstehenden ACR Convergence 2025 vorzustellen, das vom 24. bis 29. Oktober in Chicago stattfindet.

Die Präsentation wird sich auf Obecabtagene autoleucel (obe-cel), eine CD19-targetierte CAR-T-Zell-Therapie, konzentrieren, die bei Patienten mit schwerer refraktärer systemischer Lupus erythematosus (srSLE) eingesetzt wird. Erste Ergebnisse zeigen ein günstiges Sicherheitsprofil mit keiner dosislimitierenden Toxizitäten, kein ICANS und kein Grad-≥2-Cytokine-Release-Syndrom. Die Studie zeigte Verbesserungen des SLEDAI-2K-Scores und klinische Vorteile bei allen Patienten, wobei drei Patienten eine vollständige renale Reaktion erzielten.

Autolus Therapeutics (Nasdaq: AUTL) قد أعلنت أنها ستعرض البيانات السريرية المحدثة من دراسة CARLYSLE في المؤتمر القادم Convergence 2025 للجمعية الأمريكية للروماتologi، المقرر عقده من 24 إلى 29 أكتوبر في شيكاغو.

سيتركز العرض على obecabtagene autoleucel (obe-cel)، وهي علاج CAR T-cell يستهدف CD19، في علاج المرضى المصابين بـ حمى الذئبة الحمامية الجهازية الشديدة المقاومة (srSLE). تُظهر النتائج الأولية ملف سلامة مفضل مع عدم وجود سمية محددة بالجرعة، ولا ICANS، ولا متلازمة إطلاق سيتوكينات من الدرجة ≥2. أظهرت الدراسة تحسينات في درجة SLEDAI-2K وفوائد سريرية عبر جميع المرضى، مع تحقيق ثلاثة مرضى لاستجابة كلية كاملة.

Autolus Therapeutics (纳斯达克:AUTL)宣布将于即将举行的美国风湿病学会年度大会(ACR Convergence 2025)上公布 CARLYSLE 研究的更新临床数据,会议定于10月24日至29日在芝加哥举行。

此次报告将聚焦于 obecabtagene autoleucel (obe-cel),一种靶向 CD19 的 CAR-T 细胞治疗,用于治疗 重度难治性全身性红斑狼疮(srSLE) 患者。初步发现显示安全性特征有利:无剂量限制性毒性,无 ICANS,以及无≥2 级的细胞因子释放综合征。研究显示 SLEDAI-2K 评分改善,在所有患者中均有临床获益,且有三名患者达到完全肾脏反应。

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LONDON and GAITHERSBURG, Md., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces the online publication of an abstract submitted to the American College of Rheumatology (ACR) Convergence 2025, to be held October 24-29, 2025, in Chicago. Autolus will have a poster presentation, which will include updated follow up from the CARLYSLE study in patients with severe refractory systemic lupus erythematosus (srSLE).

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: Initial findings from the ongoing CARLYSLE study of obe-cel in srSLE show a manageable safety profile, with no dose limiting toxicities (DLTs), immune effector cell-associated neurotoxicity syndrome (ICANS) or Grade ≥2 cytokine release syndrome (CRS). SLEDAI-2K score reduction and clinical benefit were observed in all patients. In addition, three patients who had a complete renal response. Updated data will be presented at the conference.

About Autolus Therapeutics plc 
Autolus Therapeutics plc (Nasdaq: AUTL) is an early 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, AUCATZYL®, 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

Contact:  

Amanda Cray 
+1 617-967-0207 
a.cray@autolus.com 


FAQ

When will Autolus Therapeutics (AUTL) present at ACR Convergence 2025?

Autolus will present on Tuesday, October 28, 2025, from 10:30am to 12:30pm Central Time at ACR Convergence 2025 in Chicago.

What are the initial results of Autolus' CARLYSLE study for lupus treatment?

Initial results showed a manageable safety profile with no dose limiting toxicities, improved SLEDAI-2K scores, clinical benefits in all patients, and complete renal response in three patients.

What is obe-cel and how is it being used in Autolus' lupus study?

Obe-cel is a CD19-targeting autologous CAR T-cell therapy with a fast off-rate binding domain, being studied in patients with severe, refractory systemic lupus erythematosus (srSLE).

Who is presenting Autolus' CARLYSLE study results at ACR 2025?

Dr. Maria Leandro will be the presenting author of the CARLYSLE study results at ACR Convergence 2025.
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