CERo Therapeutics Announces Activation of the University of California, Davis as a Clinical Trial Site for the Ongoing Phase 1 CERTAIN-T Trial of CER-1236 in Hematologic Malignancies
UC Davis now combines clinical trial participation with its existing role as CER-1236's primary manufacturing site.
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) activated the University of California, Davis as a clinical site for its ongoing Phase 1 CERTAIN-T trial of CER-1236.
UC Davis also serves as the primary manufacturing site. CERo expects activation to expand recruitment capacity and streamline treatment logistics. Previously reported findings covered six patients in two cohorts. All three second-cohort patients completed the 28-day dose-limiting toxicity assessment without a dose-limiting toxicity. 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. One patient with refractory acute myeloid leukemia subsequently underwent donor stem cell transplantation 71 days after infusion. The protocol was amended to include myelodysplastic syndromes and myelofibrosis.
Positive
- Minor point. Forward-looking: it has not happened yet and may not happen.UC Davis activated for CERTAIN-T; CERo expects expanded recruitment capacity and streamlined treatment logistics.
- Minor pointThree second-cohort patients completed the 28-day assessment without dose-limiting toxicity.
- Minor pointJune 2026 safety update reported no cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or treatment-related severe adverse events during the dose-limiting toxicity assessment window.
- Minor pointPreliminary investigator observations noted clinical improvement in two patients.
- Minor pointProtocol expanded to include myelodysplastic syndromes and myelofibrosis.
Negative
- Minor pointFormal response assessments remain ongoing; limited patient numbers preclude definitive safety or efficacy conclusions.
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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, today announced that the University of California, Davis (UC Davis), has been activated as a clinical trial site for CERTAIN-T, the Company's ongoing Phase 1 study evaluating CER-1236 in patients with hematologic malignancies. UC Davis also serves as the primary manufacturing site for CER-1236.
The activation of UC Davis is expected to expand patient recruitment capacity while leveraging the site's existing manufacturing capabilities to streamline treatment logistics.
Brian Jonas, M.D., Professor, clinician-scientist, and Chief of the Division of Malignant Hematology, Cellular Therapy and Transplantation in the Department of Internal Medicine at the UC Davis School of Medicine and UC Davis Comprehensive Cancer Center and study investigator on the trial, commented, “We are excited to join with CERo Therapeutics to open this important clinical trial. We look forward to being able to offer a novel and innovative chimeric engulfment receptor-based treatment option for our patients with myeloid malignancies.”
Chris Ehrlich, CERo Therapeutics CEO added, "The addition of UC Davis represents another important milestone in our collaboration, expanding our longstanding relationship beyond manufacturing to include patient enrollment in the CERTAIN-T study. Integrating manufacturing and clinical operations at a single institution has the potential to expand patient access while shortening the time between cell manufacturing and patient infusion. We have been encouraged by the interest we've received from investigators and institutions evaluating participation in the CERTAIN-T trial, and we are pleased to welcome the UC Davis team."
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. The study protocol has been amended to include MDS and myelofibrosis.
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, AML with measurable residual disease (MRD), 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
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What does UC Davis's activation mean for CERo's CERTAIN-T trial?
UC Davis is now a clinical trial site for the ongoing Phase 1 study of CER-1236 in hematologic malignancies. It also serves as the primary manufacturing site. CERo expects the activation to expand recruitment capacity and streamline treatment logistics.
What preliminary results has CERo reported from the CERTAIN-T trial?
Previously reported findings covered six patients in the first two cohorts, with preliminary investigator observations of clinical improvement in two patients. All three second-cohort patients completed the 28-day dose-limiting toxicity assessment without a dose-limiting toxicity. Formal response assessments remain ongoing, and no definitive safety or efficacy conclusions can be drawn.