Core Insights - CERo Therapeutics Holdings, Inc. has made significant progress in its CertainT-1 trial for acute myeloid leukemia (AML), completing the dose-limiting toxicity (DLT) observation period for the first cohort and administering a higher dose of CER-1236 to the first patient in the second cohort [1][3] Group 1: Trial Progress - The first patient in the second cohort received a dose of 4e6 cells/kg of CER-1236, which is four times higher than the 1e6 cells/kg administered to the first cohort [1] - An additional dose was provided to a second patient in the first cohort, who remains on study, indicating ongoing enrollment and dosing in the Phase 1 clinical trial [3] Group 2: Study Design and Objectives - The Phase 1/1b study is designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with relapsed/refractory AML, those in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated MDS/AML or AML [2] - Primary outcome measures include the 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) [2] Group 3: Company Overview - CERo Therapeutics is focused on developing next-generation engineered T cell therapeutics for cancer treatment, utilizing a proprietary approach that integrates innate and adaptive immunity [4] - The company’s novel cellular immunotherapy platform aims to redirect patient-derived T cells toward tumor cells, employing phagocytic activity to destroy cancer cells, which may offer advantages over currently approved CAR-T therapies [4]
CERo Therapeutics Provides Clinical Update on Phase 1 Clinical Trial of CER-1236 in AML (CertainT-1)