SOUTH SAN FRANCISCO, Calif. — February 4, 2026 — Leads & Copy — CERo Therapeutics Holdings, Inc., (OTCQB: CERO), an innovative cellular immunotherapy company, will present data from its Phase 1 clinical trial of CER-1236 at the Tandem Meeting of the American Society of Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR) on February 5, 2026.
The data, reflective of a recent clinical update, highlights results from the trial’s first cohort, showcasing a positive safety and tolerability profile and rapid in vivo cell expansion. Cell expansion of approximately 20–70-fold was observed, peaking between days 7–14, followed by prolonged persistence.
The presentation includes outcomes from an index patient with acute myeloid leukemia (AML) that progressed from myelodysplastic syndrome (MDS). This patient received four CER-1236 infusions over five months at the lowest dose level.
Prior to CER-1236 treatment, the patient required frequent platelet transfusions. Following treatment, the patient developed transfusion independence lasting over two months, exceeding the ≥56-day durability benchmark.
CERo Therapeutics Chief Medical Officer, Robert Sikorski, M.D., Ph.D., noted that CER-1236 is a first-in-class TIM-4L–targeting cell therapy. Early clinical findings have demonstrated a favorable safety and tolerability profile, with no dose-limiting toxicities and no observed cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) in the first four treated patients. Sikorski stated that these early observations support continued clinical evaluation of CER-1236 in myeloid disease settings.
The first-in-human, multi-center, open-label, Phase 1/1b study was 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 began 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 the incidence of adverse events (AEs) and serious adverse events (SAEs), the 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 Therapeutics CEO Chris Ehrlich stated that the acceptance of the late-breaking abstract highlights scientific interest in CER-1236 and the program’s progress. Ehrlich added that while CER-1236 has demonstrated broad potential across multiple tumor types in preclinical studies, the emergence of early clinical observations in AML and MDS underscores the relevance of this approach in myeloid disease settings.
The Company continues to advance the CERTAIN-T trial, with the second cohort now underway and enrollment ongoing. Ehrlich said that the company remains focused on the careful and deliberate execution of the dose-escalation phase and the systematic collection of safety data, and looks forward to sharing additional updates with regulatory authorities and other stakeholders as the study progresses.
CERo is an immunotherapy company focused on advancing next-generation engineered T cell therapeutics for cancer treatment. CERo’s approach to T cell engineering integrates key functional attributes of both innate and adaptive immunity within a single therapeutic construct, designed to engage the body’s immune repertoire for more comprehensive tumor targeting. CERo has initiated clinical trials for its lead product candidate, CER-1236, for hematologic malignancies.
The poster is available for viewing and will be presented the evening of February 5, 2026, during a “Meet the Poster Authors” session. It can also be viewed as part of a Form 8-K filed by the Company.
Source: CERo Therapeutics Holdings, Inc.
