CERO Therapeutics Holdings, Inc. announced on September 8, 2025, that it has administered a second dose to the second patient in the first cohort of its Phase 1 CER-1236 clinical trial for acute myeloid leukemia (AML). This multi-dose intensification was authorized by the study’s Institutional Review Board (IRB).
The authorization followed a review of initial pharmacokinetic data from the first two enrolled patients, which showed cell expansion. This protocol modification will effectively double the amount of cell product infused in each subject relative to the previous approach, aiming to evaluate the feasibility and safety of multiple infusions and assess the implications of increased dosing.
Robert Sikorski, M.D., Ph.D., CERO’s Chief Medical Officer, noted that this modification will provide valuable information regarding dosing, safety, and feasibility as the company advances toward completion of the cohort. CEO Chris Ehrlich highlighted this as meaningful progress in clinical development efforts, alongside strengthened intellectual property protection.
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