Cellectis to Present a Development Update for eti-cel at ASH 2025
Cellectis (NASDAQ: CLLS) announced two accepted posters for ASH 2025 (Dec 6–9, 2025) in Orlando reporting clinical updates on allogeneic CAR-T programs eti-cel (UCART20x22) and lasme-cel (UCART22).
Preliminary eti-cel Phase 1 results show an 86% ORR and 57% CR at the current dose (n=7); Cellectis plans to present the full Phase 1 dataset, including low-dose IL-2 combination cohorts, in 2026. A preclinical signal suggests low-dose IL-2 may deepen and extend anti-tumor activity.
The lasme-cel poster reports a correlation between alemtuzumab exposure and depth of response in BALLI-01, identifying a threshold exposure linked to higher CR/CRi rates without increased toxicities and supporting planned pivotal Phase 2 enrollment in Q4 2025.
Cellectis (NASDAQ: CLLS) ha annunciato due poster accettati per ASH 2025 (6-9 dicembre 2025) a Orlando, riportando aggiornamenti clinici sui programmi allogenici CAR-T eti-cel (UCART20x22) e lasme-cel (UCART22).
I risultati preliminari di eti-cel in FASE 1 mostrano un ORR dell'86% e un CR del 57% alla dose attuale (n=7); Cellectis prevede di presentare l'insieme completo del dataset di FASE 1, comprese le coorti di combinazione con bassa dose di IL-2, nel 2026. Un segnale preclinico suggerisce che la bassa dose di IL-2 possa approfondire ed estendere l'attività antitumorale.
Il poster di lasme-cel riporta una correlazione tra l'esposizione all'alemtuzumab e la profondità della risposta nel BALLI-01, identificando una soglia di esposizione associata a tassi più alti di CR/CRi senza aumentare le tossicità e supportando l'iscrizione prevista al registro di Fase 2 decisivo nel Q4 2025.
Cellectis (NASDAQ: CLLS) anunció dos pósteres aceptados para ASH 2025 (del 6 al 9 de diciembre de 2025) en Orlando, reportando actualizaciones clínicas sobre programas CAR-T alogénicos eti-cel (UCART20x22) y lasme-cel (UCART22).
Los resultados preliminares de eti-cel en Fase 1 muestran un ORR del 86% y un CR del 57% en la dosis actual (n=7); Cellectis planea presentar el conjunto completo del conjunto de datos de Fase 1, incluidas las cohortes de combinación con IL-2 de dosis baja, en 2026. Una señal preclínica sugiere que una dosis baja de IL-2 podría profundizar y extender la actividad antitumoral.
El póster de lasme-cel reporta una correlación entre la exposición al alemtuzumab y la profundidad de respuesta en BALLI-01, identificando una exposición umbral vinculada a tasas más altas de CR/CRi sin aumentar las toxicidades y respaldando la inscripción prevista en la Fase 2 pivotal en Q4 2025.
Cellectis (NASDAQ: CLLS)는 올랜도에서 열리는 ASH 2025 (2025년 12월 6-9일) 에 두 개의 포스터를 수락했다고 발표했으며, 알로제네 CAR-T 프로그램인 eti-cel (UCART20x22) 및 lasme-cel (UCART22)에 대한 임상 업데이트를 보고합니다.
eti-cel의 1상(Phase 1) 예비 결과는 현재 용량에서 ORR 86%, CR 57%를 보이며(해당 데이터 n=7); Cellectis는 IL-2 저용량 병용 코호드를 포함한 1상 전체 데이터 세트를 2026년 발표할 계획입니다. 전임상 신호로 IL-2 저용량이 항종양 활성을 더 깊고 오래 지속시킬 수 있음이 시사됩니다.
lasme-cel 포스터는 BALLI-01에서 알렘투주맙(alemtuzumab) 노출과 반응의 깊이 사이의 상관관계를 보고하며, CR/CRi가 높은 비율로 나타나는 노출 임계값을 식별하고 독성 증가 없이 계획된 2상 결정적 진입을 2025년 4분기에 지지합니다.
Cellectis (NASDAQ: CLLS) a annoncé deux posters acceptés pour ASH 2025 (du 6 au 9 décembre 2025) à Orlando, rapportant des mises à jour cliniques sur les programmes CAR-T allogéniques eti-cel (UCART20x22) et lasme-cel (UCART22).
Les résultats préliminaires de eti-cel en phase 1 montrent une ORR de 86% et CR de 57% à la dose actuelle (n=7); Cellectis prévoit de présenter l’ensemble complet des données de phase 1, y compris les cohortes de combinaison à faible dose d’IL-2, en 2026. Un signal préclinique suggère qu'une faible dose d’IL-2 pourrait approfondir et prolonger l’activité anti-tumorale.
Le poster de lasme-cel rapporte une corrélation entre l’(exposition à l’alemtuzumab) et la profondeur de réponse dans BALLI-01, identifiant un seuil d’exposition lié à des taux plus élevés de CR/CRi sans augmentation des toxicités, et soutenant l’inscription phase 2 pivotale prévue au Q4 2025.
Cellectis (NASDAQ: CLLS) gab zwei akzeptierte Posters für ASH 2025 (6.–9. Dezember 2025) in Orlando bekannt und berichtete über klinische Updates zu allogenen CAR-T-Programmen eti-cel (UCART20x22) und lasme-cel (UCART22).
Die vorläufigen eti-cel Ergebnisse der Phase 1 zeigen eine ORR von 86% und eine CR von 57% bei der aktuellen Dosis (n=7); Cellectis plant, den vollständigen Phase-1-Datensatz, einschließlich der Dosisniedrig-IL-2-Kombinationskohorten, im 2026 zu präsentieren. Ein präklinisches Signal deutet darauf hin, dass eine niedrige IL-2-Dosis die antitumorale Aktivität vertiefen und verlängern könnte.
Der lasme-cel Poster berichtet eine Korrelation zwischen der Alemtuzumab-Exposition und der Tiefe der Ansprechrate im BALLI-01, identifiziert eine Expositionsschwelle, die mit höheren CR/CRi-Raten verbunden ist, ohne erhöhte Toxizitäten, und unterstützt die geplante pivotal Phase-2-Einschreibung im Q4 2025.
Cellectis (NASDAQ: CLLS) أعلنت عن قبول منشورين لـ ASH 2025 (6–9 ديسمبر 2025) في أورلاندو، مع تقارير حول تحديثات سريرية لبرامج CAR-T المتطوعة eti-cel (UCART20x22) و lasme-cel (UCART22).
تُظهر نتائج المرحلة 1 الأولية لـ eti-cel معدل استجابة مرضية وظيفياً ORR 86% وCR 57% عند الجرعة الحالية (العينة n=7)؛ تخطط سيليكتس لعرض مجموعة بيانات المرحلة 1 الكاملة، بما في ذلك كوورت عمليات الدمج بجرعات IL-2 منخفضة، في 2026. إشارة ما قبل سريرية تقترح أن جرعة IL-2 المنخفضة قد تعمق وتطول النشاط المضاد للأTumor.
يبلغ منشور lasme-cel عن علاقة بين التعرض لـ الألمتموزوماب وعمق الاستجابة في BALLI-01، مع تحديد عتبة تعرض مرتبطة بمعدلات CR/CRi أعلى دون زيادة السمية، ودعم الإعداد للالتحاق الحاسم بالمرحلة 2 المخطط في Q4 2025.
- Eti-cel preliminary 86% ORR (n=7)
- Eti-cel preliminary 57% CR (4 of 7 patients)
- Full eti-cel Phase 1 dataset including IL-2 cohorts expected in 2026
- Alemtuzumab exposure threshold linked to higher CR/CRi without added toxicity
- Eti-cel preliminary results are from a small cohort of n=7
- Full clinical impact of IL-2 combination not yet shown pending 2026 dataset
- Preliminary data recently shared for eti-cel (UCART20x22) show an
86% ORR and a57% CR rate (n=7), underscoring its potential to improve outcomes in r/r NHL - Preclinical data demonstrated that combining eti-cel with low-dose IL-2 may deepen and extend anti-tumor activity in patients with r/r NHL
- Eti-cel full Phase 1 dataset, including low-dose IL-2 combination cohorts, expected to be presented in 2026
- Correlation between alemtuzumab exposure and response with lasme-cel (UCART22) allows optimization of efficacy without an increase in toxicities
NEW YORK, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, announced today the acceptance of two abstracts for poster presentation at the American Society of Hematology (ASH) 2025 annual meeting taking place from December 6 to 9, 2025, in Orlando, FL.
First poster – Development update on eti-cel
The first poster provides a development update on eti-cel product candidate (UCART20x22), an allogeneic dual CAR-T targeting CD20 and CD22 being developed in Phase 1 of the NATHALI-01 clinical trial, for patients with relapsed/refractory non Hodgkin lymphoma (r/r NHL). In addition, the poster outlines the addition of low dose interleukin-2 (IL-2) to further deepen and extend anti-tumor activity of eti-cel in patients with r/r NHL, supported by compelling preclinical data.
Cellectis unveiled preliminary results on eti-cel, which demonstrate an encouraging overall response rate (ORR) of
“We are excited by the progress and evolution of the eti-cel program with the addition of IL-2, which promises to build on the encouraging preliminary response rates observed in the Phase 1 program,” said Adrian Kilcoyne, MD, MPH, MBA, Chief Medical Officer at Cellectis. “We look forward to sharing the full Phase 1 dataset including the IL-2 cohorts expected in 2026.”
Poster title: Trial in progress: Open-label dose-finding and dose-expansion study to evaluate the safety, expansion, persistence, and clinical activity of UCART20x22 in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) NATHALI-01
Presenter: Vivian Dai, Senior Director, Clinical Research Scientist at Cellectis
Date/Time: December 7, 2025 at 6:00 PM – 8:00 PM ET
Room: OCCC – West Halls B3-B4
Second poster – Correlation between alemtuzumab exposure and response with lasme-cel
The second poster highlights the correlation between alemtuzumab exposure and depth of response in the difficult-to-treat patients who have received lasme-cel (UCART22) in the course of the Phase 1 of BALLI-01, a clinical trial testing this allogeneic CAR-T product candidate targeting CD22 in relapsed/refractory acute lymphoblastic leukemia (ALL). Additionally, the data identifies a threshold exposure level of alemtuzumab above which achieving a complete response/complete response with incomplete hematologic recovery (CR/CRi) is more likely without any increase in toxicities.
“We strongly believe in the critical role of alemtuzumab in optimizing responses in these heavily pretreated patients,” said Adrian Kilcoyne, MD, MPH, MBA, Chief Medical Officer at Cellectis. “These data have confirmed this and demonstrated that we could further enhance the high CR/CRi and minimal residual disease (MRD)-negative rates observed in our Phase 1 program. We look forward to starting enrollment in our pivotal Phase 2 program in Q4 2025.”
Poster title: Increased alemtuzumab exposure correlates with improved responses in heavily pretreated R/R ALL patients: Analysis of the BALLI-01 trial
Presenter: Xenia Naj, Ph.D., Director Translational Sciences at Cellectis
Date/Time: December 8, 2025, 6:00 PM - 8:00 PM
Room: OCCC - West Halls B3-B4
These abstracts can now be accessed here
About Cellectis
Cellectis is a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies. The company utilizes an allogeneic approach for CAR T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients, and a platform to develop gene therapies in other therapeutic indications. With its in-house manufacturing capabilities, Cellectis is one of the few end-to-end gene editing companies that controls the cell and gene therapy value chain from start to finish.
Cellectis’ headquarters are in Paris, France, with locations in New York and Raleigh, NC. Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS). To find out more, visit www.cellectis.com and follow Cellectis on LinkedIn and X.
Cautionary Statement
This press release contains “forward-looking” statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “designed to,” “believe,” “could,” “expect,” “expected,” “look forward,” “may,” “promise,” or the negative of these and similar expressions. These forward-looking statements, which are based on our management’s current expectations and assumptions and on information currently available to management, include statements regarding the potential of the Phase 2 BALLI-01 trial to be a registrational phase, the advancement, timing and progress of clinical trials (including with respect to patient enrollment and follow-up), the timing of our presentation of data and submission of regulatory filings, the sufficiency of cash to fund operations, the potential benefit of our product candidates and technologies. These forward-looking statements are made in light of information currently available to us and are subject to significant risks and uncertainties, including with respect to the numerous risks associated with biopharmaceutical product candidate development. Furthermore, many other important factors, including those described in our Annual Report on Form 20-F as amended and in our annual financial report (including the management report) for the year ended December 31, 2024 and subsequent filings Cellectis makes with the Securities Exchange Commission from time to time, which are available on the SEC’s website at www.sec.gov, as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
For further information on Cellectis, please contact:
Media contacts:
Pascalyne Wilson, Director, Communications, + 33 (0)7 76 99 14 33, media@cellectis.com
Patricia Sosa Navarro, Chief of Staff to the CEO, +33 (0)7 76 77 46 93
Investor Relations contact:
Arthur Stril, Chief Financial Officer & Chief Business Officer, investors@cellectis.com
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FAQ
What eti-cel (UCART20x22) results will Cellectis (CLLS) present at ASH 2025?
When and where will the eti-cel poster (CLLS) be presented at ASH 2025?
What does the lasme-cel (UCART22) poster for Cellectis (CLLS) report about alemtuzumab?
How does the alemtuzumab finding affect Cellectis' clinical plans (CLLS)?
Will Cellectis (CLLS) present full eti-cel IL-2 combination data at ASH 2025?
