CERo Therapeutics Holdings, Inc. Announces Initial Clinical Trial Site for its Phase 1 Clinical Trial of CER-1236 in Acute Myeloid Leukemia
CERo Therapeutics (Nasdaq: CERO) has announced its first clinical trial site for the Phase 1 study of CER-1236 in acute myeloid leukemia (AML). The trial will be conducted at The University of Texas MD Anderson Cancer Center, led by Dr. Abhishek Maiti.
The first-in-human, multi-center, open-label Phase 1/1b study will evaluate CER-1236's safety and preliminary efficacy in patients with AML that is either relapsed/refractory, has measurable residual disease, or has TP53 gene mutation. The study consists of two parts: dose escalation to determine the highest tolerated dose and an expansion phase.
Primary outcome measures include adverse events monitoring, dose- toxicities, and response rates. Patient enrollment is ongoing, with first dosing expected in H1 2025.
CERo Therapeutics (Nasdaq: CERO) ha annunciato il suo primo sito di sperimentazione clinica per lo studio di Fase 1 di CER-1236 nella leucemia mieloide acuta (LMA). La sperimentazione sarà condotta presso il Centro Oncologico MD Anderson dell'Università del Texas, sotto la direzione del Dr. Abhishek Maiti.
Lo studio di Fase 1/1b, primo nel suo genere, multicentrico e a etichetta aperta, valuterà la sicurezza e l'efficacia preliminare di CER-1236 in pazienti con LMA che sono in recidiva/rifrangenti, presentano malattia residua misurabile o hanno una mutazione del gene TP53. Lo studio è composto da due parti: l'escalation della dose per determinare la dose massima tollerata e una fase di espansione.
Le misure primarie degli esiti includono il monitoraggio degli eventi avversi, le tossicità legate alla dose e i tassi di risposta. L'arruolamento dei pazienti è in corso, con la prima somministrazione prevista nel primo semestre del 2025.
CERo Therapeutics (Nasdaq: CERO) ha anunciado su primer sitio de ensayo clínico para el estudio de Fase 1 de CER-1236 en leucemia mieloide aguda (LMA). El ensayo se llevará a cabo en el Centro Oncológico MD Anderson de la Universidad de Texas, dirigido por el Dr. Abhishek Maiti.
El estudio de Fase 1/1b, el primero en humanos, multicéntrico y abierto, evaluará la seguridad y la eficacia preliminar de CER-1236 en pacientes con LMA que son en recaída/refractarios, tienen enfermedad residual medible o presentan una mutación en el gen TP53. El estudio consta de dos partes: escalación de dosis para determinar la dosis máxima tolerada y una fase de expansión.
Las medidas de resultado primarias incluyen el monitoreo de eventos adversos, toxicidades por dosis y tasas de respuesta. La inscripción de pacientes está en curso, con la primera dosificación esperada en el primer semestre de 2025.
CERo Therapeutics (Nasdaq: CERO)는 급성 골수성 백혈병(AML)에 대한 CER-1236의 1상 연구를 위한 첫 번째 임상 시험 사이트를 발표했습니다. 이 연구는 텍사스 대학교 MD 앤더슨 암 센터에서 아비셰크 마이티 박사가 이끌고 진행됩니다.
인간을 대상으로 하는 첫 번째 다기관 공개 라벨 1/1b 연구는 재발/불응성 AML 환자, 측정 가능한 잔여 질병이 있는 환자 또는 TP53 유전자 변이를 가진 환자에서 CER-1236의 안전성과 초기 효능을 평가합니다. 이 연구는 최대 내약 용량을 결정하기 위한 용량 증가와 확장 단계의 두 부분으로 구성됩니다.
주요 결과 측정 기준에는 부작용 모니터링, 용량-독성 및 반응률이 포함됩니다. 환자 등록은 진행 중이며, 첫 번째 투여는 2025년 상반기에 예정되어 있습니다.
CERo Therapeutics (Nasdaq: CERO) a annoncé son premier site d'essai clinique pour l'étude de Phase 1 de CER-1236 dans la leucémie myéloïde aiguë (LMA). L'essai sera réalisé au Centre de cancer MD Anderson de l'Université du Texas, dirigé par le Dr Abhishek Maiti.
Cette étude de Phase 1/1b, première du genre, multicentrique et à étiquette ouverte, évaluera la sécurité et l'efficacité préliminaire de CER-1236 chez des patients atteints de LMA qui sont en rechute/réfractaires, présentent une maladie résiduelle mesurable ou ont une mutation du gène TP53. L'étude se compose de deux parties : une escalade de dose pour déterminer la dose maximale tolérée et une phase d'expansion.
Les mesures des résultats primaires incluent la surveillance des événements indésirables, les toxicités liées à la dose et les taux de réponse. L'inscription des patients est en cours, avec la première administration prévue au premier semestre 2025.
CERo Therapeutics (Nasdaq: CERO) hat seinen ersten klinischen Prüfstandort für die Phase-1-Studie zu CER-1236 bei akuter myeloischer Leukämie (AML) bekannt gegeben. Die Studie wird am MD Anderson Cancer Center der Universität Texas unter der Leitung von Dr. Abhishek Maiti durchgeführt.
Die erste Studie am Menschen, eine multizentrische, offene Phase-1/1b-Studie, wird die Sicherheit und die vorläufige Wirksamkeit von CER-1236 bei Patienten mit AML bewerten, die entweder rezidiviert/refraktär sind, messbare Restkrankheit aufweisen oder eine TP53-Genmutation haben. Die Studie besteht aus zwei Teilen: einer Dosissteigerung zur Bestimmung der maximal tolerierten Dosis und einer Erweiterungsphase.
Primäre Endpunkte umfassen die Überwachung von unerwünschten Ereignissen, Dosis-Toxizitäten und Ansprechquoten. Die Patientenrekrutierung ist im Gange, mit der ersten Dosis, die im ersten Halbjahr 2025 erwartet wird.
- Initiated Phase 1/1b trial for CER-1236 in AML
- Secured prestigious MD Anderson Cancer Center as first trial site
- Patient enrollment already underway
- Early-stage Phase 1 trial with no efficacy data yet
- Results and potential commercialization still years away
Insights
The announcement of CERo's first clinical trial site at MD Anderson represents a procedural milestone in their development pathway, though not a significant de-risking event. The trial design targeting specific AML subpopulations - relapsed/refractory, measurable residual disease, or TP53-mutated - addresses particularly challenging patient groups with treatment options. The TP53 mutation cohort is especially notable as these patients typically have dismal outcomes with conventional therapies.
CER-1236 appears to utilize a novel engineered T cell approach incorporating phagocytic mechanisms, potentially differentiating it from traditional CAR-T therapies by engaging cellular "eating" processes rather than just cytotoxic functions. However, this remains an entirely experimental mechanism with no validated clinical proof in humans yet.
The two-part study design with dose escalation followed by expansion is standard protocol for Phase 1 oncology trials. While the company is tracking toward first patient dosing in H1 2025, investors should recognize that meaningful data readouts would likely extend well into late 2025 or beyond. Phase 1 trials primarily establish safety parameters, with efficacy signals being preliminary and often not predictive of later-stage success.
The MD Anderson site selection provides some external validation but represents an expected operational step rather than a surprising scientific advancement.
For CERo's
The selection of MD Anderson Cancer Center as the trial site provides institutional credibility but doesn't materially change the risk profile or timeline to potential revenue. For a company this size, the path to Phase 2/3 trials will require significant additional capital, likely resulting in future dilutive events for current shareholders.
The target indications in AML represent substantial unmet need, particularly in TP53-mutated patients, but investors should recognize that meaningful clinical data remains distant, likely 12+ months away. While the company is meeting its operational milestones, this specific news doesn't fundamentally alter CERo's prospects or timeline.
The novel phagocytic mechanism mentioned could potentially differentiate CER-1236 from other cellular therapies if successful, but remains unproven. This announcement confirms continued execution but doesn't provide new information to substantially shift the investment thesis in either direction.
SOUTH SAN FRANSCISCO, Calif., April 09, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces its first clinical trial site for the Company’s Phase 1 clinical trial of CER-1236. The trial is focused on patients with acute myeloid leukemia (AML), and patient enrollment is underway, with expected dosing of the first patient during the first half of 2025.
The trial will be led by Abhishek Maiti, M.D., assistant professor of Leukemia at The University of Texas MD Anderson Cancer Center.
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 acute myeloid leukemia that is either relapsed/refractory, has measurable residual disease, or has a mutation of the TP53 gene. The two-part study will begin with dose escalation to determine 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).
Chris Ehrlich, CERo Therapeutics CEO added, “It is encouraging to conduct our trial at one of the most renowned cancer centers in the United States, which we believe is a validation of the scientific work performed to date with CER-1236. The assignment of clinical trial sites is an important milestone. We look forward to announcing enrollment and first dosing in the near term.”
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, which enables it to integrate certain desirable characteristics of both innate and adaptive immunity into a single therapeutic construct, is designed to engage the body’s full immune repertoire to achieve optimized cancer therapy. This novel cellular immunotherapy platform is expected to redirect patient-derived T cells to eliminate tumors by building in engulfment pathways that employ phagocytic mechanisms to destroy cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells (“CER-T”). CERo believes the differentiated activity of CER-T cells will afford them greater therapeutic application than currently approved chimeric antigen receptor (“CAR-T”) cell therapy, as the use of CER-T may potentially span both hematological malignancies and solid tumors. CERo anticipates initiating clinical trials for its lead product candidate, CER-1236, in 2025 for hematological 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 and the implementation of its proposed plan of compliance with Nasdaq continued listing standards. 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
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