CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)
About this 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.
- Condition
- AML, Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- Tested
- CER-1236, Cyclophosphamide, Fludarabine, Mesna
- Sponsor
- CERo Therapeutics Holdings, Inc.
Who can join
- Age
- 18 to 85 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 6
- Minimum age: 18 years
- Maximum age: 85 years
- Study condition: AML, Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- 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 6
- 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
5 sites, 5 recruiting
Colorado Blood Cancer Institute
Denver, Colorado, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Sarah Cannon Research Insitute
Nashville, Tennessee, United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Potential match only. Final eligibility is determined by the study team.