On November 3, 2026 CERo Therapeutics Holdings, Inc. (OTCQB: CERO) ("CERo" or the "Company"), an innovative cellular immunotherapy company advancing next-generation engineered T cell therapeutics that employ phagocytic mechanisms, reported that it has completed dosing for the fourth patient of the second cohort (7th patient overall) in its Phase 1 CER-1236 clinical trial (CERTAIN-T) in hemotologic malignancies, including acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and myelofibrosis (MF). Investigators have completed the initial seven days of follow-up after infusion and protocol-defined safety, pharmacokinetic, pharmacodynamic, and clinical activity endpoint monitoring is ongoing.
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The Company has now treated seven patients in its Phase 1 trial. In the previous three patients treated in the Second cohort, no dose-limiting toxicities were observed during the DLT assessment period. As previously reported, CERo has also observed expansion of infused CER-1236 cells following administration, supporting continued evaluation of CER-1236’s pharmacokinetic and pharmacodynamic profile as the study advances through dose escalation.
Robert Sikorski, M.D., Ph.D., CERo Chief Medical Officer, stated, "Having expanded our clinical trial sites, we continue to make progress in the CERTAIN-T study. As we proceed in accordance with the clinical protocol, our priority remains the careful evaluation of the safety, tolerability, pharmacokinetic profile, and any preliminary clinical activity of CER-1236. The planned inclusion of patients with MDS and MF reflects our interest in exploring CER-1236 across additional hematologic malignancies with significant unmet need and further assessing the potential of its differentiated phagocytic CAR-T mechanism."
The first-in-human, multicenter, open-label Phase 1/1b study is designed to evaluate the safety and preliminary efficacy of CER-1236. The trial was initially focused on AML patients, including those with relapsed/refractory disease, measurable residual disease, or newly diagnosed TP53-mutated AML, and has since expanded to include transfusion-dependent MDS ("TD-MDS"), high-risk MDS ("HR-MDS"), and post-JAK inhibitor MF. Primary endpoints include safety and tolerability, while secondary endpoints include pharmacokinetics and measures of clinical response, including overall response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD).
CERo Chief Executive Officer Chris Ehrlich added, "We have carefully and diligently executed this trial over two cohorts and continue to be encouraged by the outcomes seen to date. We look forward to reporting our progress."
(Press release, Cero Therapeutics, NOV 3, 2026, View Source [SID1234674123])