CERo Therapeutics Announces Dose Intensification in Phase 1 Study of CER-1236 in Acute Myeloid Leukemia

Core Insights - CERo Therapeutics Holdings, Inc. has administered a second dose in the second patient of its Phase 1 CER-1236 clinical trial for acute myeloid leukemia (AML), with the new protocol allowing for double the cell product infusion compared to the previous approach [1][3] - The study aims to evaluate the safety and preliminary efficacy of CER-1236 in various AML patient populations, including those who are relapsed/refractory or newly diagnosed with TP53 mutated MDS/AML [3][4] - The recent protocol modification is expected to provide valuable insights into dosing, safety, and feasibility as the study progresses [3] Company Overview - CERo is focused on developing next-generation engineered T cell therapeutics for cancer treatment, utilizing a proprietary approach that integrates characteristics of both innate and adaptive immunity [4] - The company’s lead product candidate, CER-1236, is designed to redirect patient-derived T cells to eliminate tumors through phagocytic mechanisms, potentially offering advantages over existing CAR-T therapies [4] Clinical Trial Details - The Phase 1/1b study is structured in two parts: an initial dose escalation phase to determine the highest tolerated dose, followed by an expansion phase to evaluate safety and efficacy [3] - Primary outcome measures include the incidence of adverse events, dose-limited toxicities, and overall response rates, while secondary measures focus on pharmacokinetics [3]