Announcement • May 11
Cero Therapeutics Holdings, Inc. Completes Second Ascending Dose Cohort of Phase 1 Cer-1236 Trial CERo Therapeutics Holdings, Inc. announced that it has completed dosing and the 28-day dose-limiting toxicity assessment period for all three patients in the second cohort of its Phase 1 CERTAIN-T clinical trial of CER-1236 in hematologic malignancies. In the second cohort, patients received CER-1236 at a total dose of 4 × 106 cells/kg, administered as a split dose on Day 0 and Day 2. No dose-limiting toxicities were observed through the dose-limiting toxicity assessment window, supporting continued dose escalation in accordance with the clinical protocol. The observed safety profile remains consistent with clinical data presented at the Tandem Meetings in February, which reported no cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, dose-limiting toxicities, or treatment-related severe adverse events during the dose-limiting toxicity assessment window. CERo is now escalating to the planned 1 × 107 cells/kg split-dose cohort and is screening patients for enrollment. This next cohort is expected to include patients with myelodysplastic syndrome and myelofibrosis, reflecting the Company’s strategy to evaluate CER-1236 in myeloid disease settings characterized by inflammatory bone marrow microenvironments and impaired hematopoiesis. The Company has now treated six patients in its Phase 1 trial. In the most recent cohort of three patients, CER-1236 was administered at an increased dose level, with no dose-limiting toxicities observed during the dose-limiting toxicity 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. 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, high-risk 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, complete response, composite complete response, and measurable residual disease. Announcement • Apr 15
CERo Therapeutics Holdings, Inc. Doses Third Patient In Cohort 2 Of Phase 1 CER-1236 Trial CERo Therapeutics Holdings, Inc. announced it has dosed the third patient in the second cohort (sixth patient overall) in its Phase 1 CER-1236 clinical trial in hematologic malignancies. The patient had MDS that evolved to acute myeloid leukemia (AML). The trial was recently expanded to include earlier forms of MDS and myelofibrosis (MF). The study continues to progress in accordance with protocol, with patients undergoing monitoring for safety, pharmacokinetics, pharmacodynamics, and clinical activity. With more than seven days of follow-up completed after the most recent infusion, CERo continues to evaluate key endpoints across dose levels as it advances through dose escalation. As previously presented at the February Tandem Meetings in Salt Lake City, CER-1236 has demonstrated no reported cases of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade, and no dose-limiting toxicities observed during the 28-day assessment window. Investigators also reported in vivo cell expansion, with peak levels observed between days 10 and 14 following infusion. Additionally, as previously reported, a single patient with inv(3) AML who received four CER-1236 infusions over five months at the lowest dose level achieved 72 consecutive days of platelet transfusion independence. These findings informed the protocol amendment expanding enrollment into patients with MDS and MF. The first-in-human, multi-center, 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 myelofibrosis (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). Announcement • Apr 02
CERo Therapeutics Holdings, Inc. announced delayed annual 10-K filing On 04/01/2026, CERo Therapeutics Holdings, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. 
