Tests CER-1236 cell therapy in adults with relapsed or hard-to-treat acute myeloid leukemia
Tests CER-1236, a patient's own engineered immune cells, in adults with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)
Key facts
- Where
- Denver, Houston, Nashville, Sacramento, and Seattle, United StatesSee the 5 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT06834282, who can take part
Where in United States
- Colorado Blood Cancer InstituteDenver, United StatesTaking people
- The University of Texas MD Anderson Cancer CenterHouston, United StatesTaking people
- Sarah Cannon Research InsituteNashville, United StatesTaking people
- University of California Davis Comprehensive Cancer CenterSacramento, United StatesTaking people
- Fred Hutchinson Cancer CenterSeattle, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- CERo Therapeutics Holdings, Inc.
- Trial code
- NCT06834282
- Record updated
- 21 October 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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.