CERo Therapeutics Announces Dose Intensification in Phase 1 Study of CER-1236 in Acute Myeloid Leukemia
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
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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
[email protected]
Investors:
CORE IR
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