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CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)
Phase 1/1b First-in-human Study of Autologous Chimeric Engulfment Receptor T-Cell CER-1236 in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Myelofibrosis (CertainT-1)
Who can join
Ages 18 to 85 · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- CER-1236 (drug)
- Cyclophosphamide (drug)
- Fludarabine (drug)
- Mesna (drug)
Sponsor: CERo Therapeutics Holdings, Inc. · Participants: 18 · Started: Apr 7, 2025
Contact the study team
Official record on ClinicalTrials.gov — NCT06834282
Locations in the U.S.
| California | University of California, Davis Comprehensive Cancer Center, Sacramento |
| Colorado | Colorado Blood Cancer Institute, Denver |
| Tennessee | Sarah Cannon Research Insitute, Nashville |
| Texas | The University of Texas MD Anderson Cancer Center, Houston |
| Washington | Fred Hutchinson Cancer Center, Seattle (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.