CERo Therapeutics Doses First Patient With CER-1236 in Phase 1 Clinical Trial for Acute Myeloid Leukemia and is Advancing Through Protocol-Defined Evaluations

CERo Therapeutics Holdings, Inc. recently announced 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, MD, 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, MD, PhD,, CERo Therapeutics’ Chief Medical Officer, said “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.”

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.