CERo Therapeutics Initiates Second Cohort of Phase 1 Clinical Trial of CER-1236 in AML with Patient Receiving Significant Increase in Dosing
Rhea-AI Summary
CERo Therapeutics (OTC PINK: CERO) initiated the second cohort of its first-in-human Phase 1/1b trial of CER-1236 in acute myeloid leukemia on Nov 5, 2025. The first patient in cohort 2 received an initial dose equal to twice the cohort‑1 starting dose and a second identical dose 48 hours later. Investigators reported no dose‑limiting toxicities to date, supporting escalation. The open‑label, multi‑center study uses dose escalation to find a Phase 2 dose and an expansion phase to assess safety and preliminary efficacy with endpoints including AEs/SAEs, DLTs, ORR, CR, cCR, MRD and PK.
The company noted observed cell expansion and continues dosing while evaluating options to list the stock on a public exchange.
Positive
- Second cohort initiated in Phase 1/1b trial (CER-1236)
- No dose‑limiting toxicities observed to date
- Cohort 2 dosing doubled versus cohort 1 starting dose
- Observed cell expansion reported during trial
Negative
- One patient in cohort 1 did not receive planned second dose due to disease progression
- Public exchange listing for CERO remains under evaluation (uncertain timing)
News Market Reaction
On the day this news was published, CERO gained 14.53%, reflecting a significant positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
SOUTH SAN FRANCISCO, Calif, Nov. 05, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (OTC PINK: CERO) (“CERo” or the “Company”), an innovative cellular immunotherapy company pursuing new targets and novel phagocytic mechanisms, announces the initiation of the second cohort of its Phase 1 CER-1236 clinical trial focused on patients with acute myeloid leukemia (AML). The first patient in the cohort (the fourth patient in the trial) received an initial dose of CER-1236 at twice the initial dose of the patients in the first cohort, with a follow-on second identical dose 48 hours later.
Stephen Strickland, Jr., M.D., MSCI, director of Leukemia Research for Sarah Cannon Research Institute (SCRI) and study investigator on the trial where the patient is being dosed noted, “The initiation of this second cohort is a significant event as it demonstrates that CER-1236 showed no dose limiting toxicity to date. Thus, it was determined that this increased dose level could continue to provide insight on the safety and efficacy of the compound.”
The first-in-human, multi-center, open label, Phase 1/1b study is 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 MDS/AML or AML. The two-part study initiated with dose escalation to determine the highest tolerated dose and recommended dose for Phase 2, 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 limited 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).
CERo CEO Chris Ehrlich said, “We remain encouraged by the progress and results of our ongoing Phase 1 trial of CER-1236 given the safety data and cell expansion seen to date. The safety results observed thus far in the trial, which have included those recorded from subsequent dosing following the initial doses, have guided the strategy to significantly increase the dosing in this cohort, which we believe will be very instructive as we continue to determine a Phase 2 dose. In the meantime, we wish to emphasize that CERo remains focused on the development of CER-1236 and remains open for business as we evaluate the best way to move forward with regard to our stock being listed on a public exchange. In the meantime, we diligently continue this study and look forward to sharing outcomes as they become available.”
Of note, the Company had previously indicated that the third patient in the first cohort would receive a second dose of CER-1236. However, based on the progress of that patient’s disease, investigators determined they would not administer that additional dose to that patient.
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 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. This novel cellular immunotherapy platform is designed to redirect patient-derived T cells toward tumor cells through both adaptive perforin/granzyme pathways and innate engulfment mechanisms. The latter employ phagocytic activity to destroy cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells (“CER-T”). CERo believes the differentiated targeting properties of CER-T cells may offer advantages compared with currently approved CAR-T therapies and could potentially extend the reach of cellular immunotherapy to both hematologic malignancies and solid tumors. CERo has initiated clinical trials for its lead product candidate, CER-1236, for hematologic 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
FAQ
What did CERo announce about CER-1236 on Nov 5, 2025 (CERO)?
Why was cohort 2 dosing increased in the CER-1236 Phase 1 trial (CERO)?
What are the primary endpoints of the CER-1236 Phase 1/1b study (CERO)?
Did CERo report any clinical signals from CER-1236 dosing (CERO)?
How does the trial design determine the Phase 2 dose for CER-1236 (CERO)?
