CERo Therapeutics Holdings, Inc. Announces TriStar Centennial Medical Center as a Clinical Trial Site for its Phase 1 Clinical Trial of CER-1236 in Acute Myeloid Leukemia
CERo Therapeutics announces TriStar Centennial Medical Center as a clinical trial site for its Phase 1 study of CER-1236 in treating acute myeloid leukemia (AML). The trial, conducted through Sarah Cannon Research Institute in Nashville, Tennessee, is currently enrolling patients with expected first dosing in H1 2025.
The first-in-human, multi-center study will evaluate CER-1236's safety and efficacy in patients with AML that is either relapsed/refractory, has measurable residual disease, or has TP53 gene mutation. The two-part study includes dose escalation and expansion phases, focusing on safety metrics and response rates.
Dr. Stephen Strickland, Director of Leukemia Research at SCRI, highlighted CER-1236's promising preclinical results showing cancer cell targeting while preserving healthy cells. CEO Chris Ehrlich emphasized the significance of securing TriStar Centennial as a trial site, indicating strong confidence in CER-1236's potential.
CERo Therapeutics annuncia che il TriStar Centennial Medical Center sarà un sito per la sperimentazione clinica del suo studio di Fase 1 su CER-1236 per il trattamento della leucemia mieloide acuta (AML). Lo studio, condotto tramite il Sarah Cannon Research Institute di Nashville, Tennessee, sta attualmente reclutando pazienti con la prima somministrazione prevista nella prima metà del 2025.
Questo studio multicentrico di prima somministrazione nell'uomo valuterà la sicurezza e l'efficacia di CER-1236 in pazienti con AML recidivante/refrattaria, con malattia residua misurabile o con mutazione del gene TP53. Lo studio, articolato in due fasi di escalation e di espansione della dose, si concentrerà su parametri di sicurezza e tassi di risposta.
Il dottor Stephen Strickland, Direttore della Ricerca sulla Leucemia presso SCRI, ha sottolineato i promettenti risultati preclinici di CER-1236, che dimostrano il targeting delle cellule tumorali preservando quelle sane. Il CEO Chris Ehrlich ha evidenziato l'importanza di avere TriStar Centennial come sito di sperimentazione, segnalando grande fiducia nel potenziale di CER-1236.
CERo Therapeutics anuncia al TriStar Centennial Medical Center como sitio para el ensayo clínico de su estudio de Fase 1 con CER-1236 en el tratamiento de la leucemia mieloide aguda (LMA). El ensayo, realizado a través del Sarah Cannon Research Institute en Nashville, Tennessee, está actualmente reclutando pacientes, con la primera dosificación prevista para la primera mitad de 2025.
Este estudio multicéntrico de primera administración en humanos evaluará la seguridad y eficacia de CER-1236 en pacientes con LMA en recaída/refractaria, con enfermedad residual medible o con mutación del gen TP53. El estudio de dos partes incluye fases de escalada y expansión de dosis, enfocándose en métricas de seguridad y tasas de respuesta.
El Dr. Stephen Strickland, Director de Investigación en Leucemia en SCRI, destacó los prometedores resultados preclínicos de CER-1236 que muestran la capacidad de atacar células cancerosas preservando las sanas. El CEO Chris Ehrlich resaltó la importancia de asegurar a TriStar Centennial como sitio de ensayo, indicando gran confianza en el potencial de CER-1236.
CERo Therapeutics가 급성 골수성 백혈병(AML) 치료를 위한 CER-1236 1상 임상시험 장소로 TriStar Centennial Medical Center를 발표했습니다. 이 시험은 테네시주 내슈빌에 위치한 Sarah Cannon Research Institute를 통해 진행되며, 현재 환자 모집 중이며 첫 투여는 2025년 상반기로 예정되어 있습니다.
이 인체 최초 다기관 연구는 재발/불응성 AML, 측정 가능한 잔류 질환, 또는 TP53 유전자 변이가 있는 환자들을 대상으로 CER-1236의 안전성과 효능을 평가합니다. 연구는 용량 증량 및 확장 단계로 나뉘며, 안전성 지표와 반응률에 중점을 둡니다.
SCRI 백혈병 연구 책임자인 Stephen Strickland 박사는 건강한 세포를 보존하면서 암세포를 표적하는 CER-1236의 유망한 전임상 결과를 강조했습니다. CEO Chris Ehrlich는 TriStar Centennial을 시험 장소로 확보한 것이 CER-1236의 잠재력에 대한 강한 신뢰를 나타낸다고 강조했습니다.
CERo Therapeutics annonce que le TriStar Centennial Medical Center sera un site d'essai clinique pour son étude de Phase 1 sur CER-1236 dans le traitement de la leucémie myéloïde aiguë (LMA). L'essai, mené par le Sarah Cannon Research Institute à Nashville, Tennessee, recrute actuellement des patients avec une première administration prévue au premier semestre 2025.
Cette étude multicentrique de première administration chez l'humain évaluera la sécurité et l'efficacité de CER-1236 chez des patients atteints de LMA en rechute/réfractaire, avec maladie résiduelle mesurable ou mutation du gène TP53. L'étude en deux parties comprend des phases d'escalade et d'expansion de dose, se concentrant sur les critères de sécurité et les taux de réponse.
Le Dr Stephen Strickland, directeur de la recherche sur la leucémie à SCRI, a souligné les résultats précliniques prometteurs de CER-1236 montrant une action ciblée sur les cellules cancéreuses tout en préservant les cellules saines. Le PDG Chris Ehrlich a insisté sur l'importance d'avoir TriStar Centennial comme site d'essai, témoignant d'une forte confiance dans le potentiel de CER-1236.
CERo Therapeutics gibt bekannt, dass das TriStar Centennial Medical Center als Studienzentrum für die Phase-1-Studie von CER-1236 zur Behandlung der akuten myeloischen Leukämie (AML) fungiert. Die Studie, durchgeführt durch das Sarah Cannon Research Institute in Nashville, Tennessee, rekrutiert derzeit Patienten, mit der ersten Dosierung voraussichtlich im ersten Halbjahr 2025.
Die multizentrische First-in-Human-Studie wird die Sicherheit und Wirksamkeit von CER-1236 bei Patienten mit rezidivierender/refraktärer AML, messbarer Restkrankheit oder TP53-Genmutation untersuchen. Die zweiphasige Studie umfasst eine Dosissteigerungs- und eine Erweiterungsphase, wobei der Fokus auf Sicherheitsparametern und Ansprechraten liegt.
Dr. Stephen Strickland, Leiter der Leukämieforschung bei SCRI, hob die vielversprechenden präklinischen Ergebnisse von CER-1236 hervor, die eine gezielte Wirkung auf Krebszellen bei gleichzeitiger Schonung gesunder Zellen zeigen. CEO Chris Ehrlich betonte die Bedeutung, TriStar Centennial als Studienzentrum zu gewinnen, was großes Vertrauen in das Potenzial von CER-1236 signalisiert.
- New prestigious clinical trial site (TriStar Centennial Medical Center) added for CER-1236 Phase 1 trial, indicating strong site recruitment
- First patient dosing expected in H1 2025, showing trial progress on schedule
- CER-1236 demonstrated selective cancer cell killing in preclinical studies without harming healthy cells
- Trial design includes multiple patient populations (relapsed/refractory AML, measurable residual disease, TP53 mutation) expanding potential market opportunity
- Still in early Phase 1 stage with no human efficacy data yet
- Complex trial design with multiple endpoints could increase development time and costs
- No preliminary efficacy data available yet from human trials
Insights
CERo's Phase 1 AML trial advances with prestigious site secured and enrollment underway, marking positive clinical development progress.
CERo Therapeutics' announcement represents a significant operational milestone in their clinical development program for CER-1236. Securing TriStar Centennial Medical Center through Sarah Cannon Research Institute as a clinical trial site adds substantial credibility to their Phase 1/1b study. SCRI is widely recognized for oncology research excellence, and their participation signals confidence in CERo's approach.
The trial design follows standard clinical development methodology with a dose escalation phase to establish safety parameters and determine the highest tolerated dose, followed by an expansion phase to gather preliminary efficacy data. The company has disclosed clear primary endpoints focusing on safety (adverse events, dose-limiting toxicities) alongside efficacy measures (response rates, complete response rates).
Enrollment progress with expected first patient dosing in H1 2025 establishes a defined near-term timeline. For clinical-stage biotechs, site activation and patient enrollment are critical operational hurdles that often cause delays, so this progress demonstrates execution capability. The focus on three AML patient populations (relapsed/refractory, measurable residual disease, or TP53 mutation) shows a targeted approach to areas of significant unmet need.
CERo's CER-1236 represents an intriguing approach to AML treatment through its novel mechanism leveraging phagocytic mechanisms. This approach differentiates it from many existing AML therapies. The preclinical data suggesting cancer cell killing without harming healthy cells addresses a fundamental challenge in current treatments that often cause significant toxicity.
The focus on three specific AML patient populations is particularly notable. Relapsed/refractory AML remains challenging with poor outcomes using existing therapies. Measurable residual disease (MRD) positive patients face high relapse risk, making this an important intervention point. Most significantly, patients with TP53 mutations represent one of the most difficult-to-treat subgroups with dismal prognosis and limited effective options.
The multifunctional killing mechanism described suggests potential for overcoming resistance pathways that limit current therapies. While still at an early clinical stage, therapies that can successfully target these difficult AML subgroups would address significant unmet needs. The structured approach to both safety and efficacy endpoints will provide important preliminary data on whether CER-1236's novel mechanism translates from preclinical promise to clinical potential.
SOUTH SAN FRANCISCO, Calif., April 30, 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 TriStar Centennial Medical Center, through Sarah Cannon Research Institute (SCRI), in Nashville, Tennessee, is a clinical trial site for the Company’s Phase 1 clinical of CER-1236. Collaborating with SCRI to advance cancer research, TriStar Centennial offers innovative clinical research trials for various disease indications. 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.
Stephen Strickland, Jr., M.D., MSCI, Director of Leukemia Research for SCRI, an investigator on the trial, commented, “In preclinical studies, CER-1236 was demonstrated to have a multifunctional approach to killing cancer cells, without sacrificing healthy cells. We believe that this novel mechanism of action may have significant impact on the way we treat cancer and are looking forward to participating in the clinical studies to investigate that possibility.”
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, “The rapid uptake of clinical trial site partners is a testament to both the scientific work performed to date with CER-1236 and the dedication and acumen of the teams at CERO and the research institutions where the trial will be conducted. It is well known that the assignment of clinical trial sites is a central milestone, and the prestige TriStar Centennial Medical Center, through SCRI, brings to the trial cannot be over-emphasized. We look forward to announcing enrollment and initial 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 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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