CERo Therapeutics Holdings, Inc., (NASDAQ:CERO) ("CERo" or the "Company") an innovative cellular immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces it has administered a second dose in the second patient in the first cohort of its Phase 1 CER-1236 clinical trial focused on patients with acute myeloid leukemia (AML). The multi-dose intensification has been authorized by the study's Institutional Review Board (IRB) following review of initial pharmacokinetic data from the first two enrolled patients showing cell expansion and will effectively double the amount of cell product infused in each subject relative to the previous protocol approach.
\Robert Sikorski, M.D., Ph.D., CERo's Chief Medical Officer, noted, "The recent modification to our study will allow us to evaluate the feasibility and safety of administering multiple infusions of CER-1236 in patients with AML and to assess the implications of increased dosing in this Phase 1 study. We appreciate the collaboration of our study centers, IRB, and the FDA, and we look forward to monitoring outcomes from this second patient and proceeding toward enrollment of the third patient in the cohort."
In addition, study investigator Abhishek Maiti, M.D., assistant professor of Leukemia at The University of Texas MD Anderson Cancer Center, presented a poster outlining the study protocol (prior to the additional dose) at the Society of Hematologic Oncology's 13th annual meeting in Houston, Tex. The poster, titled, "First-in-human study of autologous chimeric engulfment receptor T-cell CER-1236 targeting TIM-4-l in acute myeloid leukemia (CertainT-1)," was presented on September 3, 2025 at the George R. Brown Convention Center.