CERo Therapeutics Initiates Second Cohort of Phase 1 Clinical Trial of CER-1236 in AML with Patient Receiving Significant Increase in Dosing
CERo Therapeutics (OTC PINK: CERO) initiated the second cohort of its first-in-human Phase 1/1b trial of CER-1236 in acute myeloid leukemia on Nov 5, 2025. The first patient in cohort 2 received an initial dose equal to twice the cohort‑1 starting dose and a second identical dose 48 hours later. Investigators reported no dose‑limiting toxicities to date, supporting escalation. The open‑label, multi‑center study uses dose escalation to find a Phase 2 dose and an expansion phase to assess safety and preliminary efficacy with endpoints including AEs/SAEs, DLTs, ORR, CR, cCR, MRD and PK.
The company noted observed cell expansion and continues dosing while evaluating options to list the stock on a public exchange.
CERo Therapeutics (OTC PINK: CERO) ha avviato la seconda coorte del suo primo test sull'uomo di fase 1/1b di CER-1236 per leucemia mieloide acuta il 5 novembre 2025. Il primo paziente della coorte 2 ha ricevuto una dose iniziale pari al doppio della dose iniziale della coorte 1 e una seconda dose identica 48 ore più tardi. Gli investigatori hanno riportato nessuna tossicità dose-limitante finora, a supporto dell'aumento della dose. Lo studio in apertura, multicentrico, usa l'aumento di dose per individuare una dose di Fase 2 e una fase di espansione per valutare sicurezza ed efficacia preliminare con endpoint tra cui AEs/SAEs, DLT, ORR, CR, cCR, MRD e PK.
L'azienda ha osservato un'espansione delle cellule e continua a somministrare dosi mentre valuta opzioni per quotare le azioni su una borsa pubblica.
CERo Therapeutics (OTC PINK: CERO) inició la segunda cohorte de su ensayo en humanos de fase 1/1b de CER-1236 en leucemia mieloide aguda el 5 de noviembre de 2025. El primer paciente de la cohorte 2 recibió una dosis inicial igual al doble de la dosis inicial de la cohorte 1 y una segunda dosis idéntica 48 horas después. Los investigadores reportaron sin toxicidades dosis‑limitantes hasta la fecha, respaldando la escalada. El estudio abierto, multicéntrico, utiliza el escalado de dosis para hallar una dosis de Fase 2 y una fase de expansión para evaluar seguridad y eficacia preliminar con endpoints que incluyen AEs/SAEs, DLTs, ORR, CR, cCR, MRD y PK.
La compañía señaló una expansión observada de células y continúa dosificando mientras evalúa opciones para listar sus acciones en una bolsa pública.
CERo Therapeutics (OTC PINK: CERO) 는 급성 골수성 백혈병에 대한 인간 대상 1상/1b 시험의 두 번째 코호트를 CER-1236에서 시작했습니다. 날짜는 2025년 11월 5일입니다. 코호트 2의 첫 환자는 코호트 1의 시작 용량의 두 배에 해당하는 초기 용량을 받고 48시간 후 동일한 용량을 추가로 투여받았습니다. 연구자들은 지금까지 용량 제한 독성이 없다고 보고하여 용량 상승을 뒷받침했습니다. 개방형 다기관 연구로서 이 연구는 용량 증가를 통해 2상 용량을 찾고 확장 단계에서 안전성 및 예비 효능을 평가하기 위해 AEs/SAEs, DLTs, ORR, CR, cCR, MRD 및 PK를 엔드포인트로 포함합니다.
회사 측은 관찰된 세포 확장을 보고했고 공공 거래소에 주식 상장을 모색하는 옵션을 평가하는 동안 투여를 계속하고 있습니다.
CERo Therapeutics (OTC PINK: CERO) a lancé la deuxième cohorte de son essai de phase 1/1b chez l'homme de CER-1236 dans la leucémie myéloïde aiguë le 5 novembre 2025. Le premier patient de la cohorte 2 a reçu une dose initiale équivalant au double de la dose de départ de la cohorte 1 et une seconde dose identique 48 heures plus tard. Les investigateurs ont reporté aucune toxicité limitant la dose à ce jour, soutenant l'escalade. L'étude ouverte, multicentrique, utilise une escalade des doses pour trouver une dose de phase 2 et une phase d'expansion pour évaluer la sécurité et l'efficacité préliminaire avec des critères tels que AEs/SAEs, DLTs, ORR, CR, cCR, MRD et PK.
L'entreprise a noté une expansion cellulaire observée et poursuit les dosages tout en évaluant des options pour référencer l'action sur une bourse publique.
CERo Therapeutics (OTC PINK: CERO) hat die zweite Kohorte ihrer ersten-in-human Phase-1/1b-Studie von CER-1236 bei akuter myeloischer Leukämie am 5. November 2025 eingeleitet. Der erste Patient in der Kohorte 2 erhielt eine Anfangsdosis, die dem Doppelten der startenden Dosis der Kohorte 1 entspricht, und eine zweite identische Dosis 48 Stunden später. Die Prüfer berichteten bisher keine dosislimitierenden Toxizitäten, was eine Eskalation unterstützt. Die Open-Label-, Multicenter-Studie verwendet eine Dosissteigerung, um eine Phase-2-Dosis zu finden, und eine Expansionsphase, um Sicherheit und vorläufige Wirksamkeit mit Endpunkten wie AEs/SAEs, DLTs, ORR, CR, cCR, MRD und PK zu bewerten.
Das Unternehmen meldete eine beobachtete Zellexpansion und setzt die Verabreichung fort, während Optionen geprüft werden, die Aktie an einer öffentlichen Börse zu listen.
CERo Therapeutics (OTC PINK: CERO) أعلنت عن بدء المجموعة الثانية من تجربتها البشرية الأولى من المرحلة 1/1b لـ CER-1236 في سرطان الدم النخاعي الحاد في 5 نوفمبر 2025. تلقّى المريض الأول في المجموعة 2 جرعة ابتدائية مساوية للضعف من جرعة البدء للمجموعة 1 وجرعة ثانية مطابقة خلال 48 ساعة لاحقة. أفاد investigators بــ لا toxicities تحدد الجرعة حتى الآن، ما يدعم التصعيد. الدراسة مفتوحة التسمية، متعددة المراكز، تستخدم تصعيد الجرعات لإيجاد جرعة المرحلة 2 ومرحلة التوسع لتقييم السلامة والفعالية الأولية مع نقاط نهاية تشمل AEs/SAEs، DLTs، ORR، CR، cCR، MRD وPK.
أشارت الشركة إلى توسيع الخلايا الملاحظ وواصلت إعطاء الجرعات أثناء تقييم خيارات لإدراج الأسهم في بورصة عامة.
- Second cohort initiated in Phase 1/1b trial (CER-1236)
- No dose‑limiting toxicities observed to date
- Cohort 2 dosing doubled versus cohort 1 starting dose
- Observed cell expansion reported during trial
- One patient in cohort 1 did not receive planned second dose due to disease progression
- Public exchange listing for CERO remains under evaluation (uncertain timing)
SOUTH SAN FRANCISCO, Calif, Nov. 05, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (OTC PINK: CERO) (“CERo” or the “Company”), an innovative cellular immunotherapy company pursuing new targets and novel phagocytic mechanisms, announces the initiation of the second cohort of its Phase 1 CER-1236 clinical trial focused on patients with acute myeloid leukemia (AML). The first patient in the cohort (the fourth patient in the trial) received an initial dose of CER-1236 at twice the initial dose of the patients in the first cohort, with a follow-on second identical dose 48 hours later.
Stephen Strickland, Jr., M.D., MSCI, director of Leukemia Research for Sarah Cannon Research Institute (SCRI) and study investigator on the trial where the patient is being dosed noted, “The initiation of this second cohort is a significant event as it demonstrates that CER-1236 showed no dose limiting toxicity to date. Thus, it was determined that this increased dose level could continue to provide insight on the safety and efficacy of the compound.”
The first-in-human, multi-center, open label, Phase 1/1b study is designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with AML that is either relapsed/refractory, or in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated MDS/AML or AML. The two-part study initiated with dose escalation to determine the highest tolerated dose and recommended dose for Phase 2, followed by an expansion phase to evaluate safety and efficacy. Primary outcome measures include incidence of adverse events (AEs) and serious adverse events (SAEs), incidence of dose limited toxicities and estimation of overall response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD). Secondary outcome measures include pharmacokinetics (PK).
CERo CEO Chris Ehrlich said, “We remain encouraged by the progress and results of our ongoing Phase 1 trial of CER-1236 given the safety data and cell expansion seen to date. The safety results observed thus far in the trial, which have included those recorded from subsequent dosing following the initial doses, have guided the strategy to significantly increase the dosing in this cohort, which we believe will be very instructive as we continue to determine a Phase 2 dose. In the meantime, we wish to emphasize that CERo remains focused on the development of CER-1236 and remains open for business as we evaluate the best way to move forward with regard to our stock being listed on a public exchange. In the meantime, we diligently continue this study and look forward to sharing outcomes as they become available.”
Of note, the Company had previously indicated that the third patient in the first cohort would receive a second dose of CER-1236. However, based on the progress of that patient’s disease, investigators determined they would not administer that additional dose to that patient.
About CERo Therapeutics Holdings, Inc.
CERo is an innovative immunotherapy company advancing the development of next generation engineered T cell therapeutics for the treatment of cancer. Its proprietary approach to T cell engineering integrates key functional attributes of both innate and adaptive immunity within a single therapeutic construct, designed to engage the body’s immune repertoire for more comprehensive tumor targeting. This novel cellular immunotherapy platform is designed to redirect patient-derived T cells toward tumor cells through both adaptive perforin/granzyme pathways and innate engulfment mechanisms. The latter employ phagocytic activity to destroy cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells (“CER-T”). CERo believes the differentiated targeting properties of CER-T cells may offer advantages compared with currently approved CAR-T therapies and could potentially extend the reach of cellular immunotherapy to both hematologic malignancies and solid tumors. CERo has initiated clinical trials for its lead product candidate, CER-1236, for hematologic malignancies.
Forward-Looking Statements
This communication contains statements that are forward-looking and as such are not historical facts. This includes, without limitation, statements regarding the financial position, business strategy and the plans and objectives of management for future operations of CERo. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this communication, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. When CERo discusses its strategies or plans, it is making projections, forecasts or forward-looking statements. Such statements are based on the beliefs of, as well as assumptions made by and information currently available to, CERo’s management.
Actual results could differ from those implied by the forward-looking statements in this communication. Certain risks that could cause actual results to differ are set forth in CERo’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and the documents incorporated by reference therein. The risks described in CERo’s filings with the Securities and Exchange Commission are not exhaustive. New risk factors emerge from time to time, and it is not possible to predict all such risk factors, nor can CERo assess the impact of all such risk factors on its business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements made by CERo or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. CERo undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Contact:
Chris Ehrlich
Chief Executive Officer
chris@cero.bio
Investors:
CORE IR
investors@cero.bio
FAQ
What did CERo announce about CER-1236 on Nov 5, 2025 (CERO)?
Why was cohort 2 dosing increased in the CER-1236 Phase 1 trial (CERO)?
What are the primary endpoints of the CER-1236 Phase 1/1b study (CERO)?
Did CERo report any clinical signals from CER-1236 dosing (CERO)?
How does the trial design determine the Phase 2 dose for CER-1236 (CERO)?
