CERo Therapeutics Doses Second Acute Myeloid Leukemia Patient with CER-1236

Rhea-AI Summary

CERo Therapeutics (NASDAQ:CERO) has announced the dosing of the second patient in its Phase 1 clinical trial of CER-1236, a novel CAR-T therapy targeting TIM 4L for acute myeloid leukemia (AML). The treatment was administered at the Sarah Cannon Research Institute at Colorado Blood Cancer Institute.

The company reported promising data from the first patient, who showed no dose-limiting toxicities during the 28-day observation period. Notably, the therapy demonstrated a 20.8-fold expansion of infused cells, peaking at 14 days post-infusion.

The Phase 1/1b study aims to evaluate CER-1236's safety and efficacy in patients with relapsed/refractory AML, AML in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated MDS/AML.

Positive

• First patient showed no dose-limiting toxicities in 28-day observation period
• Successful 20.8-fold expansion of infused cells in first patient, peaking at day 14
• Study progressing as planned with second patient dosed

Negative

• Early-stage Phase 1 trial with limited patient data
• Final efficacy and safety outcomes still unknown

Insights

Oncology Clinical Trial Expert

CERo's AML therapy shows promising early expansion results with second patient now dosed in Phase 1 trial.

CERo Therapeutics has achieved a significant milestone in its Phase 1 CER-1236 clinical trial for acute myeloid leukemia (AML) with the dosing of the second patient at Sarah Cannon Research Institute. This represents steady progression through their clinical development program for this novel CAR-T therapeutic targeting TIM 4L.

What's particularly noteworthy are the preliminary pharmacokinetic results from the first patient. The therapy demonstrated the critical ability to expand after infusion, reaching a 20.8-fold expansion at day 14 post-infusion. This expansion profile is a positive indicator in CAR-T development, as it suggests the engineered cells are actively proliferating in response to tumor antigens rather than being rapidly cleared from circulation.

The first patient also completed the 28-day dose-limiting toxicity (DLT) observation period without experiencing any dose-limiting toxicities - an encouraging safety signal for this novel immunotherapy approach. Safety is paramount in early-phase trials, especially for cell therapies that employ phagocytic mechanisms.

This first-in-human Phase 1/1b study employs a standard dose-escalation design to determine the maximum tolerated dose before moving to an expansion phase. The study focuses on multiple AML patient populations: relapsed/refractory disease, patients in remission with measurable residual disease, and newly diagnosed patients with specific mutations (TP53 mutated MDS/AML or AML).

The trial's endpoints appropriately focus on safety metrics (adverse events, serious adverse events, dose-limiting toxicities) while also examining preliminary efficacy through overall response rate, complete response, composite complete response, and measurable residual disease assessment. These are standard and appropriate endpoints for an early-phase hematologic malignancy trial.

Second patient in the first cohort is now advancing through protocol-defined evaluations as Company provides promising update on first patient pharmacokinetic results

SOUTH SAN FRANSCISCO, Calif., July 31, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: 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 first cohort of its Phase 1 CER-1236 clinical trial focused on patients with acute myeloid leukemia (AML).  The patient was dosed at the Sarah Cannon Research Institute (SCRI) at Colorado Blood Cancer Institute (CBCI) in Denver, Colorado, with Yazan Migdady, M.D., an associate member physician at CBCI acting as principal investigator for the study.  With more than seven days passed following the second patient’s infusion, monitoring continues for key safety, tolerability, and efficacy endpoints. 

Dr. Migdady noted, “The dosing of the second patient in this Phase 1 first-in-human trial is an important indicator, representing a key clinical development milestone for CER-1236, a novel autologous CAR-T therapeutic candidate targeting TIM 4L.  We believe that CER-1236 may be an important advancement in cancer immunotherapy and this second patient reflects steady progress in our clinical evaluation.  We are now conducting protocol-specified evaluations of safety, pharmacodynamic, pharmacokinetic, and efficacy endpoints, and expect to communicate progress over the course of the study.”

Previously CERo reported that the first patient treated in CertainT-1 had no dose-limiting toxicities during the 28-day DLT observation period. Further analysis of CER-1236 pharmacokinetics in this patient reveals that the therapy of infused cells expanded (e.g., the cell number multiplied) as expected upon infusion, reaching a peak at 14 days post infusion with a 20.8-fold expansion of infused cells. These are early insights into how CER-1236 functions in AML patients, and CERo will be monitoring pharmacokinetics in subsequent patients.

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 acute myeloid leukemia 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 has begun 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 are encouraged that in our very first patient treated we saw rapid and significant expansion in CER-1236 cells after infusion, a positive sign that we’re on the right track in our Phase I study, based on the extensive experience and history of the clinical development of CAR T cells.  We continue to believe that CER-1236 is a novel approach to treating cancer, and we are grateful for the participation of our first and second patients, and to the many people who have worked tirelessly to reach this milestone, including our CERO team, our consultants and study sites.  We look forward to discussing additional outcomes, which we anticipate will validate the scientific work performed to date with CER-1236.”

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

FAQ

What are the latest results from CERo Therapeutics (CERO) CER-1236 clinical trial?

CERo has dosed the second patient in its Phase 1 trial, while the first patient showed no dose-limiting toxicities and achieved a 20.8-fold expansion of infused cells after 14 days.

What type of cancer is CERo Therapeutics' CER-1236 targeting?

CER-1236 is targeting acute myeloid leukemia (AML), including cases that are relapsed/refractory, in remission with measurable residual disease, or newly diagnosed with TP53 mutated MDS/AML.

What are the primary endpoints of CERo's CER-1236 Phase 1 trial?

The primary endpoints include incidence of adverse events, serious adverse events, dose-limiting toxicities, and estimation of overall response rate, complete response, composite complete response, and measurable residual disease.

How effective was the cell expansion in CERo's first CER-1236 patient?

The first patient showed successful cell expansion with a 20.8-fold increase in infused cells, reaching peak levels at 14 days post-infusion.

Where is CERo Therapeutics conducting the CER-1236 clinical trial?

The second patient was dosed at the Sarah Cannon Research Institute at Colorado Blood Cancer Institute in Denver, Colorado, as part of a multi-center study.