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CERo Therapeutics Announces Dose Intensification in Phase 1 Study of CER-1236 in Acute Myeloid Leukemia

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CERo Therapeutics (NASDAQ:CERO) has announced a significant modification to its Phase 1 clinical trial of CER-1236 for acute myeloid leukemia (AML). The company has received IRB approval to implement dose intensification, effectively doubling the cell product infusion amount following encouraging pharmacokinetic data showing cell expansion in the first two patients.

The trial, known as CertainT-1, is evaluating CER-1236, an autologous chimeric engulfment receptor T-cell therapy. The study design includes a two-part Phase 1/1b trial focusing on patients with relapsed/refractory AML, those in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated MDS/AML.

CERo Therapeutics (NASDAQ:CERO) ha comunicato una modifica importante al suo studio di fase 1 su CER-1236 per la leucemia mieloide acuta (LMA). L'azienda ha ottenuto l'approvazione dell'IRB per intensificare la dose, raddoppiando di fatto la quantità di prodotto cellulare infuso dopo dati farmacocinetici preliminari promettenti che hanno mostrato espansione cellulare nei primi due pazienti.

Lo studio, chiamato CertainT-1, valuta CER-1236, una terapia con cellule T autologhe dotate di recettore chimerico per l'ingestione. Il disegno dello studio prevede una fase 1/1b in due parti rivolta a pazienti con LMA recidivante/refrattaria, a pazienti in remissione con malattia residua misurabile o a pazienti di nuova diagnosi con MDS/LMA con mutazione TP53.

CERo Therapeutics (NASDAQ:CERO) ha anunciado una modificación significativa en su ensayo clínico de fase 1 de CER-1236 para la leucemia mieloide aguda (LMA). La compañía recibió la aprobación del IRB para intensificar la dosis, duplicando efectivamente la cantidad del producto celular infundido tras datos farmacocinéticos alentadores que mostraron expansión celular en los dos primeros pacientes.

El ensayo, denominado CertainT-1, evalúa CER-1236, una terapia con células T autólogas con un receptor quimérico de fagocitosis. El diseño del estudio incluye una fase 1/1b en dos partes centrada en pacientes con LMA en recaída/refractaria, en remisión con enfermedad residual mensurable, o en pacientes recién diagnosticados con MDS/LMA con mutación TP53.

CERo Therapeutics (NASDAQ:CERO)� 급성 골수� 백혈�(AML) 치료� CER-1236� 1� 임상시험� 중대� 변경을 발표했습니다. 회사� IRB 승인� 받아 투여 용량� 강화했으�, 초기 � 환자에서 세포 확장� 확인� 유망� 약동� 데이터에 따라 세포 치료� 주입량을 사실� � 배로 늘리기로 했습니다.

CertainT-1으로 명명� � 임상은 자가 유래 키메� 섭식 수용체를 가� T세포 치료� CER-1236� 평가합니�. 연구 설계� 재발/불응� AML 환자, 측정 가능한 잔존 질환� 있는 관� 환자 또는 TP53 돌연변이가 있는 새로 진단� MDS/AML 환자� 대상으� 하는 2단계� 1/1b�� 포함합니�.

CERo Therapeutics (NASDAQ:CERO) a annoncé une modification importante de son essai clinique de phase 1 sur CER-1236 pour la leucémie myéloblastique aiguë (LMA). La société a obtenu l'approbation du comité d'éthique (IRB) pour intensifier la dose, doublant de fait la quantité de produit cellulaire perfusé après des données pharmacocinétiques encourageantes montrant une expansion cellulaire chez les deux premiers patients.

L'essai, nommé CertainT-1, évalue CER-1236, une thérapie par cellules T autologues porteuses d'un récepteur chimérique d'englobement. Le plan d'étude comprend une phase 1/1b en deux parties ciblant les patients atteints de LMA en rechute/réfractaire, les patients en rémission avec maladie résiduelle mesurable, ou les patients récemment diagnostiqués avec un MDS/LMA muté TP53.

CERo Therapeutics (NASDAQ:CERO) hat eine wesentliche Änderung seiner Phase�1‑Studie zu CER-1236 bei akuter myeloischer Leukämie (AML) bekanntgegeben. Das Unternehmen erhielt die IRB‑Zulassung zur Dosisintensivierung und verdoppelt damit effektiv die Menge des infundierten Zellprodukts, nachdem vielversprechende pharmakokinetische Daten eine Zellvermehrung bei den ersten beiden Patienten gezeigt hatten.

Die Studie CertainT-1 untersucht CER-1236, eine autologe T‑Zell‑Therapie mit chimärem Engulfment‑Rezeptor. Das Studiendesign umfasst eine zweiteilige Phase 1/1b, die sich auf Patienten mit rezidivierender/refraktärer AML, Patienten in Remission mit messbarer residueller Erkrankung oder neu diagnostizierte Patienten mit TP53‑mutiertem MDS/AML konzentriert.

Positive
  • Initial pharmacokinetic data shows promising cell expansion in first two patients
  • IRB approval received for dose intensification protocol
  • Study protocol enhancement allows for evaluation of multiple infusions
Negative
  • Still in early Phase 1 stage with only two patients treated so far
  • Safety and efficacy data not yet available

Insights

CERo's dose intensification in Phase 1 AML trial represents measured progress with potential significance for treatment-resistant leukemia patients.

CERo Therapeutics has implemented a meaningful protocol adjustment in its Phase 1 trial of CER-1236 for acute myeloid leukemia (AML) � they're now administering a second dose to patients, effectively doubling the cell product infused compared to the original protocol. This modification follows review of encouraging pharmacokinetic data showing cell expansion in the first two enrolled patients.

The significance here lies in what this tells us about the preliminary safety profile. For cellular immunotherapies, dose-limiting toxicities often appear quickly after initial administration. The fact that the IRB has authorized dose intensification suggests the safety signals thus far are acceptable enough to explore higher dosing, which is a positive early indicator for this novel platform.

CER-1236 represents an innovative approach in the cellular immunotherapy landscape. Unlike traditional CAR-T therapies that primarily use cytotoxic mechanisms, CERo's technology employs phagocytic mechanisms (essentially enabling T-cells to "eat" cancer cells rather than just attack them). This approach targeting TIM-4-l in AML could potentially address resistance mechanisms seen with other immunotherapies.

The trial design is comprehensive, evaluating CER-1236 across multiple AML populations including relapsed/refractory patients, those in remission with measurable residual disease, and newly diagnosed patients with TP53 mutations � a particularly difficult-to-treat subgroup with poor prognosis. The inclusion of pharmacokinetic measures and measurable residual disease assessment indicates a thorough evaluation of both the therapy's biological activity and clinical efficacy.

While this update represents incremental progress rather than definitive efficacy data, the protocol enhancement provides valuable information on dosing parameters that will be essential for potential future development phases. The dose escalation approach is standard for Phase 1 oncology trials, but the early authorization to intensify dosing is a modest positive signal for this experimental therapy.

Study investigator of Phase 1 trial presented poster at Society of Hematologic Oncology 13th annual conference highlighting original study protocol

SOUTH SAN FRANSCISCO, Calif., Sept. 08, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo� or the “Company�) an innovative cellular immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces it has administered a second dose in the second patient in the first cohort of its Phase 1 CER-1236 clinical trial focused on patients with acute myeloid leukemia (AML).  The multi-dose intensification has been authorized by the study’s Institutional Review Board (IRB) following review of initial pharmacokinetic data from the first two enrolled patients showing cell expansion and will effectively double the amount of cell product infused in each subject relative to the previous protocol approach. 

Robert Sikorski, M.D., Ph.D., CERo’s Chief Medical Officer, noted, “The recent modification to our study will allow us to evaluate the feasibility and safety of administering multiple infusions of CER-1236 in patients with AML and to assess the implications of increased dosing in this Phase 1 study. We appreciate the collaboration of our study centers, IRB, and the FDA, and we look forward to monitoring outcomes from this second patient and proceeding toward enrollment of the third patient in the cohort.�

In addition, study investigator Abhishek Maiti, M.D., assistant professor of Leukemia at The University of Texas MD Anderson Cancer Center, presented a poster outlining the study protocol (prior to the additional dose) at the Society of Hematologic Oncology’s 13th annual meeting in Houston, Tex.  The poster, titled, “First-in-human study of autologous chimeric engulfment receptor T-cell CER-1236 targeting TIM-4-l in acute myeloid leukemia (CertainT-1),� was presented on September 3, 2025 at the George R. Brown Convention Center.

CERo CEO Chris Ehrlich added, “This has been an important week for CERo, as the enhancement to our Phase 1 protocol for CER-1236 represents meaningful progress in our clinical development efforts, and our intellectual property protection in the United States has been further strengthened. As we closely monitor the second patient in Cohort 1 following their second dose, we are also preparing to enroll the third patient in the cohort. We expect that this protocol adjustment will provide valuable information regarding dosing, safety, and feasibility as we advance toward completion of the cohort. We continue to believe CER-1236 represents a potentially novel approach to cancer treatment, and we look forward to sharing additional updates as the study progresses.�

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, or in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated MDS/AML or AML. The two-part study has begun 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).

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 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 commenced clinical trials for its lead product candidate CER-1236 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. 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

Investors:
CORE IR


FAQ

What is the latest update on CERo Therapeutics' (CERO) Phase 1 trial of CER-1236?

CERo has received IRB approval to double the cell product infusion amount in its Phase 1 trial of CER-1236 for AML, following positive pharmacokinetic data showing cell expansion in the first two patients.

Who is eligible for the CERo Therapeutics CER-1236 clinical trial?

The trial is open to patients with relapsed/refractory AML, those in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated MDS/AML.

What are the primary outcome measures for CERO's CER-1236 Phase 1 trial?

The primary outcomes include incidence of adverse events (AEs), serious adverse events (SAEs), dose limited toxicities, overall response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD).

How many patients have been treated in the CERo CER-1236 Phase 1 trial?

Currently, two patients have been treated in the first cohort, with the second patient receiving a second dose under the new intensification protocol. The company is preparing to enroll the third patient.

What is CER-1236 and how does it work?

CER-1236 is an autologous chimeric engulfment receptor T-cell therapy targeting TIM-4-l in acute myeloid leukemia, representing a novel approach to cancer treatment using phagocytic mechanisms.
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Biotechnology
Biological Products, (no Disgnostic Substances)
United States
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