Recruiting
Phase 1

CER-1236

Sponsor:

CERo Therapeutics Holdings, Inc.

Code:

NCT06834282

Conditions

AML

Acute Myeloid Leukemia

Refractory Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CER-1236

Cyclophosphamide

Fludarabine

Mesna

Study Details

Brief summary:

This is a first in human, multi center, open label, phase 1/1b study to evaluate the safety and preliminary efficacy of CER-1236 in patients with relapsed/refractory (R/R), measurable residual disease (MRD) positive acute myeloid leukemia (AML), or TP53mut disease.

Conditions

AML

Acute Myeloid Leukemia

Refractory Acute Myeloid Leukemia

Study ID

NCT06834282

Start date

Apr 7, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients need to have a confirmed diagnosis of de novo or secondary AML, or myelodysplastic syndrome (MDS)/AML with 10% to 19% blasts, per the International Consensus Classification 2022 or the WHO 2022 classification.
  • Absolute lymphocyte count >0.3 x 109/L prior to apheresis.
  • Eastern cooperative oncology group (ECOG) performance status 0 to 1.

Exclusion Criteria:

  • Prior therapy with a permanently integrated, genetically modified cell product.
  • No measurable leukemia on the screening bone marrow evaluation prior to any bridging therapy.
  • Active autoimmune disease or history of autoimmune disease requiring treatment within the prior 2 years. Patients with history of autoimmune thyroiditis or type 1 diabetes well controlled on replacement regimen are eligible.
  • A known hypersensitivity or severe allergy to fludarabine, cyclophosphamide, or study drug components or diluents.
  • Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the physician.
  • Primary immunodeficiency disorder.

Study Design

Enrollment

18 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Single Agent CER-1236

AML patient treated with a single dose of CER-1236 monotherapy

experimental: Part 2: Single Agent CER-1236

AML patient treated with a single dose of CER-1236 monotherapy

Interventions

CER-1236

an autologous chimeric engulfment receptor T-cell

Cyclophosphamide

Lymphodepleting chemotherapy

Fludarabine

Lymphodepleting chemotherapy

Mesna

Chemoprotectant

Primary outcome measure

  • Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 1) [ Time Frame: 2 year ]
  • Incidence of dose-limiting toxicities (DLTs) of CER-1236 Monotherapy - (Part 1) [ Time Frame: 28 days ]
  • Estimation of the objective response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD) negativity rates - (Part 2) [ Time Frame: 2 years ]

Central Contacts and Locations

Locations

University of California, Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Brian Jonas, MD

916-382-6970bajonas@health.ucdavis.edu

Alpha Stem Cell Clinic

916-734-0753OCRReferral@health.ucdavis.edu

Principal Investigator:

Brian Jonas, MD

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

Contacts

Maris Michael, MD

PSLMDLCBCINewClinicPatient@HCAHealthcare.com

Principal Investigator:

Michael Maris, MD

Sarah Cannon Research Insitute

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

AskSarah Help Line Have Cancer Questions? askSARAH | Sarah Cannon

844-482-4812

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Abhishek Maiti, MD

713-745-3228amaiti@mdanderson.org

Principal Investigator:

Abhishek Maiti, MD

More Information

Sponsor

CERo Therapeutics Holdings, Inc.

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • Relapsed Acute Myeloid Leukemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CERo Therapeutics Holdings, Inc. on 2026-08-26.