On March 30, 2026 CERo Therapeutics Holdings, Inc., (OTCQB: 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, reported it has dosed the second patient in the second cohort (fifth patient overall) in its Phase 1 CER-1236 clinical trial in hematologic malignancies, including acute myeloid leukemia (AML), with planned expansion into myelodysplastic syndromes (MDS) and myelofibrosis (MF). With more than seven days of follow-up completed after the second patient’s infusion, protocol-defined monitoring of safety, pharmacokinetic, pharmacodynamic, and clinical activity endpoints is ongoing.
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As previously presented at the February Tandem Meetings in Salt Lake City, investigators reported no cases of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade, no dose-limiting toxicities during the 28-day assessment window, and in vivo cell expansion with peak levels observed between days 10 and 14 following infusion. In the same presentation, the Company reported observations from a single patient with inv(3) AML who received four CER-1236 infusions over five months at the lowest dose level and experienced 72 consecutive days of platelet transfusion independence. These data informed the protocol amendment expanding enrollment into patients with MDS and MF.
Robert Sikorski, M.D., Ph.D., CERo Chief Medical Officer, stated, "The study is progressing according to protocol, with ongoing evaluation of safety, pharmacokinetics, pharmacodynamics, and clinical activity. The data generated to date support continued dose escalation and planned expansion of enrollment into patients with advanced myelodysplastic syndrome (MDS) and myelofibrosis (MF). These are patient populations with substantial unmet need, and we are committed to continuing the clinical evaluation of CER-1236 as a potential new cell therapy approach for patients with these diseases."
The first-in-human, multi-center, open-label, Phase 1/1b study was initially designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with AML that is either relapsed/refractory, or in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated AML. The two-part study initiated with dose escalation to determine the highest tolerated dose and recommended dose for subsequent expansion, followed by an expansion phase to evaluate safety and efficacy. Primary outcome measures include incidence of adverse events (AEs) and serious adverse events (SAEs), incidence of dose-limiting toxicities and estimation of overall response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD). Secondary outcome measures include pharmacokinetics (PK). Based on emerging safety data and clinical observations, the trial has recently been amended to include transfusion-dependent myelodysplastic syndromes (TD-MDS), high-risk MDS (HR-MDS), or post-JAK-inhibitor myelofibrosis (MF).
CERo CEO Chris Ehrlich added, "CERo continues to execute the CERTAIN-T trial, with completion of the second cohort approaching. The study data continue to reinforce ongoing dose escalation and planned expansion into additional patient populations. We are grateful to the patients, investigators, study sites, and the CERo team for their contributions, and we look forward to sharing additional data as the study progresses."
(Press release, Cero Therapeutics, MAR 30, 2026, View Source [SID1234664048])