Recruiting

CertainT-1CER-1236 for Acute Myeloid Leukemia Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

CER-1236

+ Cyclophosphamide

+ Fludarabine

Drug
Who is being recruted

Hematologic Diseases+4

+ Hemic and Lymphatic Diseases

+ Leukemia

From 18 to 85 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2025
See protocol details

Summary

Principal SponsorCERo Therapeutics Holdings, Inc.
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 7, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on testing a new treatment called CER-1236 for patients with a type of blood cancer known as acute myeloid leukemia (AML), specifically those whose cancer has returned or is hard to treat. The study is particularly interested in patients who have measurable residual disease or a genetic mutation called TP53mut. The goal is to see if CER-1236, which is a special type of cell therapy that targets a specific protein involved in the cancer, is safe and effective. This research is crucial because current treatment options for these patients are limited, and finding new, effective therapies can significantly improve outcomes. The study is conducted in two parts. In the first part, different doses of CER-1236 are given to patients to determine which dose is safe and should be used in the second part. The treatment involves using the patient's own modified immune cells, which are then reintroduced to their body to attack the cancer cells. The study checks how safe the treatment is and whether it works to control the cancer. This involves closely monitoring participants for any side effects and assessing the impact of the therapy on their disease. This approach helps ensure that the treatment is not only effective but also safe for the patients involved.

Official TitlePhase 1/1b First-in-human Study of Autologous Chimeric Engulfment Receptor T-Cell CER-1236 in Patients With Acute Myeloid Leukemia (CertainT-1)
Principal SponsorCERo Therapeutics Holdings, Inc.
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hematologic DiseasesHemic and Lymphatic DiseasesLeukemiaLeukemia, MyeloidNeoplasmsNeoplasms by Histologic TypeLeukemia, Myeloid, Acute

Criteria

3 inclusion criteria required to participate
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

6 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Recruiting

Colorado Blood Cancer Institute

Denver, United StatesOpen Colorado Blood Cancer Institute in Google Maps
Recruiting

Sarah Cannon Research Insitute

Nashville, United States
Recruiting

The University of Texas MD Anderson Cancer Center

Houston, United States
Recruiting soon

University of California, Davis Comprehensive Cancer Center

Sacramento, United States
Recruiting
4 Study Centers