Core Insights - CERo Therapeutics Holdings, Inc. has initiated the second cohort of its Phase 1 clinical trial for CER-1236, targeting patients with acute myeloid leukemia (AML) [1][2] - The first patient in this cohort received an initial dose of CER-1236 at twice the initial dose given to patients in the first cohort, with a follow-up dose 48 hours later [1][2] - The trial 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 [2] Clinical Trial Details - The Phase 1/1b study is designed to assess safety and preliminary efficacy, with primary outcome measures including adverse events, dose-limiting toxicities, and overall response rates [2] - The study consists of a dose escalation phase to determine the highest tolerated dose, followed by an expansion phase to further evaluate safety and efficacy [2] - Secondary outcome measures include pharmacokinetics [2] Company Strategy and Future Outlook - The CEO of CERo expressed optimism regarding the trial's progress, highlighting the safety data and cell expansion observed so far [3] - The company is focused on the development of CER-1236 and is considering options for listing on a public exchange while continuing the clinical study [3] - CERo's innovative approach integrates innate and adaptive immunity in T cell engineering, potentially offering advantages over existing CAR-T therapies [4]
CERo Therapeutics Initiates Second Cohort of Phase 1 Clinical Trial of CER-1236 in AML with Patient Receiving Significant Increase in Dosing