Core Insights - CERo Therapeutics Holdings, Inc. announced a key clinical update regarding its CertainT-1 trial for patients with acute myeloid leukemia (AML), reporting cell expansion with no treatment-related adverse events observed to date [1][3] - The company has amended the CertainT-1 trial to include advanced myelodysplastic syndrome (MDS) and myelofibrosis (MF) as additional cohorts [2][3] - A conference call is scheduled for January 7, 2026, to discuss the trial's progress and the company's future strategy [5] Clinical Trial Update - The CertainT-1 trial has completed the dose-limiting toxicity observation period for the first cohort, with investigators noting a 61-day platelet transfusion-free interval after treatment with CER-1236, surpassing the 8-week benchmark commonly referenced in clinical studies [1][3] - The trial is designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with AML, including those who are relapsed/refractory or newly diagnosed with TP53 mutated MDS/AML [3][4] - Primary outcome measures include the incidence of adverse events, dose-limited toxicities, and overall response rate, while secondary measures focus on pharmacokinetics [3] Strategic Expansion - The inclusion of MDS and MF in the trial is seen as a significant milestone, with the company emphasizing the importance of careful dose escalation and systematic safety data collection [4] - The CEO expressed gratitude to trial participants and shareholders, highlighting the company's commitment to advancing its clinical programs [4] Company Overview - CERo is focused on developing next-generation engineered T cell therapeutics for cancer treatment, utilizing a novel cellular immunotherapy platform that integrates innate and adaptive immunity [7][8] - The company's lead product candidate, CER-1236, is currently in clinical trials for hematologic malignancies, aiming to offer advantages over existing CAR-T therapies [8]
CERo Therapeutics Provides Clinical Update on Phase 1 Trial of CER-1236 in AML (CertainT-1) Highlighting Key Safety Data and Platelet Transfusion–Free Interval Observed in a Patient with Myelodysplastic Syndrome/AML