CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)

Recruiting now · Phase 1

Conditions studied: AML, Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID: NCT06834282
Run by: CERo Therapeutics Holdings, Inc.
People needed: 18
Starts: 2025-04-07
Expected to finish: 2029-12-31
Last updated by the study team: 2026-03-27

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
Sarah Cannon Research Insitute — Nashville, Tennessee, United States (enrolling)
The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
University of California, Davis Comprehensive Cancer Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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