CERo Therapeutics Holdings, Inc. Doses First Patient with CER-1236 in Phase 1 Clinical Trial for Acute Myeloid Leukemia and is Advancing Through Protocol-Defined Evaluations
- First patient successfully dosed in Phase 1 trial for CER-1236, marking a significant clinical development milestone
- Patient has completed seven days post-infusion with ongoing monitoring
- Study is being conducted at prestigious MD Anderson Cancer Center with experienced lead investigator
- Robust preclinical data already published in peer-reviewed Clinical Cancer Research journal
- Early-stage Phase 1 trial with no efficacy data available yet
- Long development timeline ahead before potential commercialization
- Multiple clinical endpoints need to be met for success
Insights
CERo's first-in-human dosing of CER-1236 for AML represents a significant early clinical development milestone with protocol evaluations ongoing.
This announcement marks a significant early milestone in CERo's clinical development pathway. The company has successfully dosed the first patient in their Phase 1 trial for CER-1236, an autologous CAR-T therapeutic candidate targeting TIM-4L for acute myeloid leukemia (AML). The patient has progressed beyond the crucial 7-day post-infusion mark, with ongoing monitoring for safety, tolerability, and efficacy endpoints.
The trial design is particularly comprehensive, structured as a Phase 1/1b study with both dose escalation and expansion phases. The patient population is strategically selected to include multiple AML subtypes: relapsed/refractory cases, patients in remission with measurable residual disease, and newly diagnosed patients with specific genetic mutations (TP53 mutated MDS/AML).
The primary endpoints are appropriately focused on safety metrics (adverse events, serious adverse events, dose-limiting toxicities) while also collecting preliminary efficacy data through overall response rate, complete response, composite complete response, and measurable residual disease assessments. Pharmacokinetic analysis is included as a secondary endpoint.
What's particularly noteworthy is that the company has already published preclinical data in a peer-reviewed journal (Clinical Cancer Research), suggesting scientific rigor in their approach. The lead investigator from MD Anderson Cancer Center, a prestigious cancer research institution, adds credibility to the trial.
The study's presentation at ASCO, a premier oncology conference, provides an opportunity for broader scientific scrutiny and visibility. This trial represents CERo's novel approach using engineered T cells that employ phagocytic mechanisms, which differentiates their technology in the competitive cellular immunotherapy landscape.
CERO Chief Medical Officer to discuss trial protocol in poster at the American Society for Clinical Oncology Conference
The first patient has been dosed and is advancing through protocol-defined evaluations
SOUTH SAN FRANSCISCO, Calif., May 30, 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 dosed the first patient in its Phase 1 clinical trial of CER-1236. The patient was dosed at the lead trial site in a study focused on patients with acute myeloid leukemia (AML). Now more than seven days post-infusion, monitoring continues for key safety, tolerability, and efficacy endpoints. The study will be featured in a poster being presented at the 2025 Annual Meeting of the American Society of Clinical Oncology being held in Chicago May 30-June 3, 2025.
Abhishek Maiti, M.D., assistant professor of Leukemia at The University of Texas MD Anderson Cancer Center, is the lead investigator of the trial. He worked with Cero team on publishing the novel preclinical data in Clinical Cancer Research.
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).
Robert Sikorski, M.D. Ph.D., CERo Therapeutics’ Chief Medical Officer remarked, “The completion of first-in-human dosing represents a clinical development milestone for CER-1236, a novel autologous CAR-T therapeutic candidate targeting TIM 4L. Protocol-specified evaluations of safety, pharmacodynamic, pharmacokinetic, and efficacy endpoints are in progress. We look forward to communicating results as data matures.”
A peer-reviewed manuscript with robust preclinical data was published earlier in Clinical Cancer Research. The Company is presenting a poster that outlines the Phase 1/1b study at the American Society of Clinical Oncology 2025 Annual Meeting in Chicago May 30-June 3, 2025 at Chicago’s McCormick Place Convention Center. The abstract for 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)” can be found here. The poster session, at which Dr. Sikorski will be present, is being held June 1st, and is titled, “Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes and Allotransplant.”
CERo CEO Chris Ehrlich concluded, “We are grateful for the participation of our first patient and to the many people who have worked tirelessly to reach this milestone, including our CERO team, our consultants and study sites. We look forward to discussing additional outcomes, which we continue to believe will validate the scientific work performed to date with CER-1236.”
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 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
chris@cero.bio
Investors:
CORE IR
FAQ
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