Cero Therapeutics doses first patient with CER-1236 in Phase 1 trial

CERo Therapeutics (CERO) 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. 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 and serious adverse events, incidence of dose limited toxicities and estimation of overall response rate, complete response, composite complete response, and measurable residual disease. Secondary outcome measures include pharmacokinetics.