CERo Therapeutics Holdings, Inc. Announces Sarah Cannon Research Institute at Colorado Blood Cancer Institute as Key Clinical Trial Site for its Phase 1 Clinical Trial of CER-1236 in Acute Myeloid Leukemia
CERo Therapeutics (Nasdaq: CERO) announces Sarah Cannon Research Institute at Colorado Blood Cancer Institute (CBCI) as a key clinical trial site for its Phase 1 trial of CER-1236 in acute myeloid leukemia (AML). The first-in-human, multi-center study will evaluate safety and preliminary efficacy in patients with relapsed/refractory AML, measurable residual disease, or TP53 gene mutation.
The trial consists of two parts: dose escalation to determine highest tolerated dose, followed by an expansion phase. Primary outcomes include monitoring adverse events, dose toxicities, and response rates. Patient enrollment is ongoing with initial dosing expected by June.
CBCI, serving a seven-state region, is recognized as the region's leader in blood cancer care. The trial aims to leverage chimeric engulfment receptor technology to improve treatment efficacy and reduce relapse rates in AML patients.
CERo Therapeutics (Nasdaq: CERO) annuncia che il Sarah Cannon Research Institute presso il Colorado Blood Cancer Institute (CBCI) sarà un sito clinico chiave per la sua sperimentazione di Fase 1 del CER-1236 nella leucemia mieloide acuta (LMA). Lo studio, il primo sull'uomo e multicentrico, valuterà la sicurezza e l'efficacia preliminare in pazienti con LMA recidivante/refrattaria, malattia residua misurabile o mutazione del gene TP53.
La sperimentazione si articola in due fasi: un'escalation della dose per determinare la dose massima tollerata, seguita da una fase di espansione. Gli obiettivi principali includono il monitoraggio degli eventi avversi, delle tossicità da dose e dei tassi di risposta. L'arruolamento dei pazienti è in corso, con la somministrazione iniziale prevista per giugno.
CBCI, che serve una regione di sette stati, è riconosciuto come il punto di riferimento regionale per la cura dei tumori del sangue. Lo studio mira a sfruttare la tecnologia dei recettori chimerici di inglobamento per migliorare l'efficacia del trattamento e ridurre i tassi di recidiva nei pazienti con LMA.
CERo Therapeutics (Nasdaq: CERO) anuncia que el Sarah Cannon Research Institute en el Colorado Blood Cancer Institute (CBCI) será un sitio clínico clave para su ensayo de Fase 1 del CER-1236 en leucemia mieloide aguda (LMA). Este estudio multicéntrico, de primera administración en humanos, evaluará la seguridad y la eficacia preliminar en pacientes con LMA refractaria o en recaída, enfermedad residual medible o mutación en el gen TP53.
El ensayo consta de dos partes: una escalada de dosis para determinar la dosis máxima tolerada, seguida de una fase de expansión. Los resultados principales incluyen el monitoreo de eventos adversos, toxicidades por dosis y tasas de respuesta. La inscripción de pacientes está en curso, con la dosificación inicial prevista para junio.
CBCI, que atiende a una región de siete estados, es reconocido como líder regional en el cuidado del cáncer de sangre. El ensayo busca aprovechar la tecnología de receptores quiméricos de fagocitosis para mejorar la eficacia del tratamiento y reducir las tasas de recaída en pacientes con LMA.
CERo Therapeutics (나스닥: CERO)는 콜로라도 혈액암 연구소(CBCI)의 Sarah Cannon 연구소를 급성 골수성 백혈병(AML) 대상 CER-1236 1상 임상시험의 주요 시험 기관으로 발표했습니다. 이 최초의 인간 대상 다기관 연구는 재발/불응성 AML, 측정 가능한 잔류 질환 또는 TP53 유전자 돌연변이를 가진 환자들의 안전성과 초기 효능을 평가할 예정입니다.
임상시험은 최대 허용 용량을 결정하는 용량 증량 단계와 확장 단계의 두 부분으로 구성됩니다. 주요 결과는 이상 반응, 용량 독성 및 반응률 모니터링을 포함합니다. 환자 등록이 진행 중이며 초기 투여는 6월에 예정되어 있습니다.
CBCI는 7개 주 지역을 담당하며 혈액암 치료 분야에서 지역 선두 기관으로 인정받고 있습니다. 이번 임상시험은 키메릭 탐식 수용체 기술을 활용해 AML 환자의 치료 효능을 높이고 재발률을 줄이는 것을 목표로 합니다.
CERo Therapeutics (Nasdaq : CERO) annonce que le Sarah Cannon Research Institute du Colorado Blood Cancer Institute (CBCI) sera un site clinique clé pour son essai de phase 1 du CER-1236 dans la leucémie myéloïde aiguë (LMA). Cette étude multicentrique, première administration chez l'humain, évaluera la sécurité et l’efficacité préliminaire chez des patients atteints de LMA en rechute/réfractaire, avec maladie résiduelle mesurable ou mutation du gène TP53.
L’essai se compose de deux parties : une escalade de dose pour déterminer la dose maximale tolérée, suivie d’une phase d’expansion. Les critères principaux incluent la surveillance des événements indésirables, des toxicités liées à la dose et des taux de réponse. Le recrutement des patients est en cours, avec une première administration prévue en juin.
Le CBCI, qui couvre une région de sept états, est reconnu comme le leader régional dans les soins du cancer du sang. L’essai vise à exploiter la technologie des récepteurs chimériques d’englobement pour améliorer l’efficacité du traitement et réduire les taux de rechute chez les patients atteints de LMA.
CERo Therapeutics (Nasdaq: CERO) gibt bekannt, dass das Sarah Cannon Research Institute am Colorado Blood Cancer Institute (CBCI) als wichtiger Standort für die Phase-1-Studie von CER-1236 bei akuter myeloischer Leukämie (AML) fungieren wird. Die erstmalige Anwendung am Menschen in einer multizentrischen Studie soll die Sicherheit und vorläufige Wirksamkeit bei Patienten mit rezidivierender/refraktärer AML, messbarer Restkrankheit oder TP53-Genmutation untersuchen.
Die Studie besteht aus zwei Teilen: einer Dosissteigerung zur Bestimmung der maximal verträglichen Dosis, gefolgt von einer Erweiterungsphase. Primäre Endpunkte sind das Monitoring von Nebenwirkungen, Dosistoxizitäten und Ansprechraten. Die Patientenrekrutierung läuft, die erste Dosierung wird für Juni erwartet.
Das CBCI, das eine Region von sieben Bundesstaaten versorgt, gilt als führend in der Blutkrebsvorsorge in der Region. Die Studie zielt darauf ab, die chimäre Engulfment-Rezeptor-Technologie zu nutzen, um die Behandlungseffektivität zu verbessern und Rückfallraten bei AML-Patienten zu senken.
- Partnership with prestigious Sarah Cannon Research Institute and CBCI enhances trial credibility
- Trial enrollment already underway with dosing expected to begin soon
- Addresses multiple AML patient populations including hard-to-treat TP53 mutations
- Early-stage Phase 1 trial with no efficacy data yet
- Complex trial design may extend timeline to reach conclusive results
Insights
CERo's AML trial advancing with reputable site; enrollment ongoing with first patient dosing expected by June.
The addition of Sarah Cannon Research Institute at Colorado Blood Cancer Institute (CBCI) as a key site for CERo's Phase 1/1b trial represents meaningful progress in their clinical program. CBCI serves as a regional leader in blood cancer care across seven states, which should facilitate recruitment for this challenging patient population.
This study targets specific high-need AML subgroups: relapsed/refractory disease, measurable residual disease, and TP53-mutated cases. The TP53 mutation subset is particularly significant as these patients face dismal outcomes with conventional therapies and represent one of the most treatment-resistant forms of AML.
CERo's approach utilizing chimeric engulfment receptor technology is mechanistically distinct from conventional cellular therapies. Rather than directly killing cancer cells through cytotoxic mechanisms, this platform appears to leverage phagocytic processes to potentially improve tumor clearance. The two-part study design (dose escalation followed by expansion) follows standard methodology for first-in-human cellular therapy trials.
The trial's endpoint selection is appropriate, focusing on safety parameters (adverse events, dose-limiting toxicities) while incorporating preliminary efficacy measures (response rates, MRD assessment). With enrollment underway and first dosing expected by June, we're approaching a meaningful clinical milestone that will provide initial safety data and potentially early signals of biological activity in these difficult-to-treat patients.
CERo advancing AML cell therapy to dosing phase by June; trial site selection shows execution on clinical development timeline.
This announcement demonstrates CERo Therapeutics is executing on its clinical development timeline for CER-1236 in acute myeloid leukemia. The onboarding of a recognized cancer research institute strengthens their clinical trial infrastructure ahead of first patient dosing expected by June this year.
The company's strategic focus on three distinct AML patient populations (relapsed/refractory, measurable residual disease, and TP53-mutated cases) within a single trial is efficient from both clinical and regulatory perspectives. This approach allows simultaneous evaluation across multiple high-unmet-need segments where new treatment options are desperately needed.
From a pipeline perspective, the CEO's reference to "progress in launching our solid tumor study" suggests portfolio expansion beyond hematological malignancies, potentially broadening the application of their proprietary technology platform. However, no specific details or timelines for this solid tumor program were provided.
The trial design incorporating both safety and preliminary efficacy endpoints is standard for early-stage oncology studies. For stakeholders following CERo, key upcoming catalysts include:
- First patient dosing expected by June
- Safety data from initial cohorts
- Determination of recommended Phase 2 dose
- Preliminary efficacy signals in the expansion phase
While this announcement represents normal progress through clinical development rather than a transformative event, it confirms the company is advancing its lead program on schedule.
SOUTH SAN FRANSCISCO, Calif, April 24, 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 that Sarah Cannon Research Institute (SCRI) at Colorado Blood Cancer Institute (CBCI) in Denver, Colorado will be a key clinical trial site for the Company’s Phase 1 clinical trial of CER-1236. Partnering with SCRI to advance cancer research, CBCI is the region’s leader in blood cancer care and serves a seven-state region. The trial is focused on patients with acute myeloid leukemia (AML), and patient enrollment is underway with first dosing of the initial cohort of patients expected by June.
Dr. Yazan Migdady, Co-Director, Research and Clinical Innovation for the Myeloid Disease & Allogeneic Stem Cell Program at Colorado Blood Cancer Institute, an investigator in the trial, commented, "The use of chimeric engulfment receptor technology in cellular therapy for AML offers new hope for patients battling aggressive leukemia. This trial represents a crucial step forward in developing innovative therapies, enhancing patient clinical and survival outcomes by improving treatment efficacy, reducing relapse rates, and ultimately bringing a brighter future to AML patients and their families."
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, “CBCI is a world-renowned cancer center, and we believe their participation in our AML trial is continued validation of the scientific work performed to date with CER-1236. We look forward to announcing enrollment and initial dosing in the near term for this trial and to progress in launching our solid tumor study.”
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 Annual Report on Form 10-K, filed on April 15, 2025, 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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