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

RecruitingPhase 1Ages 18 Years - 85 YearsAllCERo Therapeutics Holdings, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • CER-1236
  • Cyclophosphamide
  • Fludarabine
  • Mesna
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Where

5 sites
University of California, Davis Comprehensive Cancer Center
Sacramento, United States
Colorado Blood Cancer Institute
Denver, United States
Sarah Cannon Research Insitute
Nashville, United States
The University of Texas MD Anderson Cancer Center
Houston, United States
Fred Hutchinson Cancer Center
Seattle, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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