DEC-205/NY-ESO-1 Fusion Protein CDX-1401and Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

Exclusion Criteria

• •Subjects with life-threatening illnesses other than MDS, uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study outcomes at risk
• •AML associated with inv(16); t(16;16); t(8;21) or t(15;17)
• •Subjects with uncontrolled or symptomatic arrhythmias, or any class 3 or 4 cardiac disease as defined by the New York Heart Association functional classification
• •Subjects with symptomatic central nervous system (CNS) disease which is not adequately controlled
• •Subjects who have received prior radiation therapy for extramedullary disease within 2 weeks of first dose
• •Subjects with human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV)
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• •Subjects who are being treated with systemic corticosteroids
• •Subjects who have hypersensitivity to decitabine
• •History of auto-immune disease (e.g. thyroiditis, lupus) except vitiligo
• •Pregnant or nursing female subjects
• •Unwilling or unable to follow protocol requirements
• •Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug
• •Received an investigational agent within 30 days prior to enrollment
• •Active malignancy with the exception of basal cell carcinoma, non-melanoma skin cancer, cervical carcinoma-in-situ; other prior malignancies in remission for less than 1 year
• •Subjects previously treated with an allogeneic stem cell transplant