CERo Therapeutics Announces Activation of Additional Clinical Trial Site for the CERTAIN-T Trial, its Ongoing Phase 1 Clinical Trial of CER-1236 in Hematological Cancers
The trial protocol now includes MDS and myelofibrosis, while formal response assessments remain ongoing.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
CERo Therapeutics (CERO) has activated Fred Hutch Cancer Center in Seattle as an additional site for its Phase 1 CERTAIN-T trial. The trial evaluates CER-1236 in hematological cancers, with Jacob Appelbaum serving as principal investigator at Fred Hutch.
Previously reported findings covered six patients in two cohorts. All three second-cohort patients completed the 28-day assessment without dose-limiting toxicity. A June 2026 update reported no cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, dose-limiting toxicities or treatment-related severe adverse events during that assessment window. Preliminary investigator observations noted clinical improvement in two patients, but formal response assessments remain ongoing and no definitive safety or efficacy conclusions can be drawn. The protocol has also been amended to include MDS and myelofibrosis.
Positive
- Minor pointFred Hutch Cancer Center activated as an additional site for the Phase 1 CERTAIN-T trial.
- Minor pointSecond cohort: all three patients completed the 28-day assessment without dose-limiting toxicity.
- Minor pointJune 2026 update: no cytokine release syndrome, neurological toxicity syndrome or treatment-related severe adverse events during the assessment window.
- Minor pointPreliminary investigator observations noted clinical improvement in two patients.
- Minor pointStudy protocol amended to include MDS and myelofibrosis.
Negative
- Minor pointResponse assessments remain ongoing; limited patient numbers prevent definitive safety or efficacy conclusions.
- Minor pointOne refractory AML patient's transplant course and longer-term outcome remain under evaluation.
AI-generated analysis. How Rhea-AI works. Not financial advice.
SOUTH SAN FRANCISCO, Calif, Oct. 26, 2026 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (OTCQB: CERO) (“CERo” or the “Company”), an innovative cellular immunotherapy company advancing engineered T cell therapeutics designed to engage phagocytic mechanisms, announces that Fred Hutch Cancer Center (“Fred Hutch”) in Seattle, Wash., has been activated as a clinical trial site for the Company’s Phase 1 clinical trial of CER-1236, CERTAIN-T.
Jacob Appelbaum, M.D., Ph.D., Assistant Professor, Division of Hematology and Oncology, University of Washington School of Medicine, and a physician at Fred Hutch is the principal investigator at the Fred Hutch clinical trial site.
Chris Ehrlich, CERo Therapeutics CEO said, “The outstanding quality and stellar reputations of our clinical trial sites is a tribute to the work our team has already completed to date and further validation of the excitement that the science is already generating. We are gratified to be working with these important institutions and welcome the team at Fred Hutch to our clinical trial team. We look forward to continuing to provide updates as the trial progresses.”
CERo previously reported findings from six patients treated in the first two cohorts of CERTAIN-T. All three patients in the second cohort completed the 28-day dose-limiting toxicity assessment without a DLT. In its June 2026 update, the Company reported that the observed safety profile remained consistent with earlier findings of no cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, DLTs or treatment-related severe adverse events during the DLT assessment window. Preliminary investigator observations noted clinical improvement in two patients; however, formal response assessments remain ongoing, are based on a limited number of patients, and no definitive safety or efficacy conclusions can be drawn at this time. One patient with refractory AML subsequently underwent allogeneic stem cell transplantation 71 days after CER-1236 infusion, though the transplant course and longer-term outcome remain under evaluation. The study protocol has been amended to include MDS and myelofibrosis.
Fred Hutch is the only National Cancer Institute-designated cancer center in Washington state and also serves as UW Medicine’s cancer program.
About the CERTAIN-T Trial
The first-in-human, multicenter, open-label Phase 1/1b CERTAIN-T study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of CER-1236 in patients with hematologic malignancies. The study initially enrolled patients with acute myeloid leukemia (“AML”), including relapsed/refractory AML, measurable residual disease AML, and newly diagnosed TP53-mutated AML, and the protocol has since been amended to include transfusion-dependent myelodysplastic syndromes (“TD-MDS”), high-risk myelodysplastic syndromes (“HR-MDS”), and post-JAK inhibitor myelofibrosis (“MF”). Primary endpoints include safety and tolerability. 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”).
About CERo Therapeutics Holdings, Inc.
CERo Therapeutics Holdings, Inc. is an innovative immunotherapy company advancing the development of engineered T cell therapeutics for the treatment of cancer. The Company’s proprietary approach to T cell engineering is designed to integrate characteristics of innate and adaptive immunity into a single therapeutic construct intended to engage multiple immune mechanisms against cancer. CERo refers to these engineered cells as Chimeric Engulfment Receptor T cells (“CER-T”).
The Company’s lead investigational product candidate, CER-1236, is being evaluated in hematologic malignancies.
Forward-Looking Statements
This communication contains forward-looking statements within the meaning of applicable securities laws. These statements include, without limitation, statements regarding the clinical development, safety profile, pharmacokinetic and pharmacodynamic characteristics, therapeutic potential, and future evaluation of CER-1236; the progression, design, and enrollment of the CERTAIN-T trial; planned cohort expansion and dose escalation; and the Company’s development strategy and objectives. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.
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. Forward-looking statements are not guarantees of performance, and undue reliance should not be placed on such statements. CERo undertakes no obligation to publicly update or revise 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
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
Which new site has joined CERo's CERTAIN-T trial?
Fred Hutch Cancer Center in Seattle has been activated as an additional site for the Phase 1 trial of CER-1236. Jacob Appelbaum is the site's principal investigator.
What preliminary results has CERo reported from CERTAIN-T?
Preliminary investigator observations noted clinical improvement in two patients, and all three second-cohort patients completed the 28-day assessment without dose-limiting toxicity. Findings covered six patients across the first two cohorts. Formal response assessments remain ongoing, and no definitive safety or efficacy conclusions can be drawn.
What happened after stem cell transplantation in the CER-1236 trial patient with refractory AML?
The patient's transplant course and longer-term outcome remain under evaluation. The patient underwent allogeneic stem cell transplantation, using donor cells, 71 days after CER-1236 infusion.