1. CERO announces advances in the CertainT-1 trial for AML treatment. 2. First patient in Cohort 2 received a higher cell dose of CER-1236. 3. Ongoing safety monitoring and dose escalation in the Phase 1 clinical trial. 4. CERO aims to differentiate its CER-T from existing CAR-T therapies. 5. Trial focuses on acute myeloid leukemia with measurable residual disease.
FAQ
Why Bullish?
CERO's successful dose escalation and progress in trials indicate a promising pipeline, boosting investor confidence. Historical examples, such as key trial updates from comparable biotech firms, often lead to significant price rises.
How important is it?
The ongoing clinical developments are critical for CERO’s future performance, making this news highly influential.
Why Long Term?
The long-term impact stems from potential market approval and commercial success of CER-1236, which may lead to significant revenue generation.
CERo Therapeutics Provides Clinical Update on Phase 1 Trial of CER-1236 in AML
SOUTH SAN FRANCISCO, Calif., Dec. 17, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc. (OTCQB: CERO), an innovative cellular immunotherapy company, has announced significant advancements in its Phase 1 clinical trial of CER-1236, targeting patients with acute myeloid leukemia (AML). This update follows the completion of the dose-limiting toxicity (DLT) observation period for the initial cohort of participants.
Recent Developments in the CertainT-1 Trial
The recent trial updates indicate promising progress as CERo administered a dose of 4e6 cells/kg of CER-1236 to the first patient in Cohort 2. This represents a leap in dosing, being four times greater than the 1e6 cells/kg given to patients in the first cohort. The patient in Cohort 2 has also completed the necessary observation period for DLTs.
Additionally, a fourth dose was successfully given to a second patient from Cohort 1, who continues to participate in the study.
Study Design and Objectives
The CertainT-1 trial is a first-in-human, multi-center, open-label Phase 1/1b study aimed at evaluating the safety and preliminary efficacy of CER-1236 in various AML patients, including relapsed/refractory cases and those with measurable residual disease. The two-part study focuses first on dose escalation to identify the highest tolerated dose and the recommended dose for Phase 2, followed by an expansion phase to further assess safety and efficacy.
Key primary outcome measures include:
- Incidence of adverse events (AEs) and serious adverse events (SAEs)
- Incidence of dose-limited toxicities
- Estimation of overall response rate (ORR), complete response (CR), and measurable residual disease (MRD)
Secondary outcomes will also evaluate pharmacokinetics (PK) associated with CER-1236.
Executive Insights
Chris Ehrlich, CEO of CERo, commented on the current status of the trial: “Enrollment and dosing are ongoing in our Phase 1 clinical trial of CER-1236. The first patient in the second cohort has received a higher cell dose, and safety monitoring is continuing. We are focused on the careful conduct of the dose-escalation phase and the systematic collection of safety data as the trial proceeds.”
About CERo Therapeutics Holdings, Inc.
CERo is pioneering the development of next-generation engineered T cell therapeutics aimed at treating cancer. Their proprietary T cell engineering integrates both innate and adaptive immunity to create a comprehensive therapeutic construct. The innovative platform redirects patient-derived T cells towards tumor cells through adaptive and innate mechanisms, including the targeting of the TIM-4 ligand.
CERo's Chimeric Engulfment Receptor T cells (CER-T) aim to enhance therapeutic advantages over existing CAR-T therapies, with the potential to address both hematologic malignancies and solid tumors. As part of their mission, CERo has launched clinical trials for CER-1236 specifically targeting hematologic malignancies.
Forward-Looking Statements
This announcement contains forward-looking statements regarding CERo's financial position, business strategy, and future operations. Such statements are projections and are not guarantees of performance. Key risks that may affect these outcomes are detailed in CERo's filings with the Securities and Exchange Commission. Actual results may differ significantly from those projected due to various risk factors.