Trial advancing with ongoing safety and pharmacologic evaluation and planned expansion into MDS and MF
SOUTH SAN FRANCISCO, Calif., March 30, 2026 (GLOBE NEWSWIRE) -- 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, announces 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.
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."
About CERo Therapeutics Holdings, Inc.
CERo is an innovative immunotherapy company advancing the development of next generation engineered T cell therapeutics for the treatment of cancer. Its proprietary approach to T cell engineering, which enables it to integrate certain desirable characteristics of both innate and adaptive immunity into a single therapeutic construct, is designed to engage the body's full immune repertoire to achieve optimized cancer therapy. This novel cellular immunotherapy platform is expected to redirect patient-derived T cells to eliminate tumors by building in engulfment pathways that employ phagocytic mechanisms to destroy cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells ("CER-T"). CERo believes the differentiated activity of CER-T cells will afford them greater therapeutic application than currently approved chimeric antigen receptor ("CAR-T") cell therapy, as the use of CER-T may potentially span both hematological malignancies and solid tumors. CERo has commenced clinical trials for its lead product candidate CER-1236 for hematological malignancies.
Forward-Looking Statements
This communication contains statements that are forward-looking and as such are not historical facts. This includes, without limitation, statements regarding the financial position, business strategy and the plans and objectives of management for future operations of CERo. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this communication, words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "strive," "would" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. When CERo discusses its strategies or plans, it is making projections, forecasts or forward-looking statements. Such statements are based on the beliefs of, as well as assumptions made by and information currently available to, CERo's management.
Actual results could differ from those implied by the forward-looking statements in this communication. Certain risks that could cause actual results to differ are set forth in CERo's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and the documents incorporated by reference therein. The risks described in CERo's filings with the Securities and Exchange Commission are not exhaustive. New risk factors emerge from time to time, and it is not possible to predict all such risk factors, nor can CERo assess the impact of all such risk factors on its business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements made by CERo or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. CERo undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Contact:
Chris Ehrlich
Chief Executive Officer
chris@cero.bio
Investors:
CORE IR
investors@cero.bio
