Study of GDX012 in Patients With MRD Positive AML

Exclusion Criteria

• •Cytotoxic chemotherapy within 3 weeks
• •Immune therapy within 4 weeks
• •Immunosuppressive therapy within 2 weeks (with exceptions)
• •Investigational treatment or interventional clinical trial within 4 weeks or 5 half-lives (if known), whichever is longer
• •Major surgery within 4 weeks and/or not fully recovered from surgery-related toxicities
• •Known hypersensitivity to chemotherapy, other agents, or excipients used in this study
• •Female patient that is pregnant or lactating/breastfeeding
• •Ongoing toxicity from prior anti-cancer therapy that have not recovered to ≤ Grade 1 (with exceptions)
• •History of chronic or recurrent autoimmune or immune-mediated disease requiring steroids or other immunosuppressive treatments (including anti-tumor necrosis factor agents)
• •Active CNS involvement (i.e. leukemic infiltration)
• •Any other malignancy that requires active therapy
• •Uncontrolled intercurrent illness (i.e. acute coronary syndrome in the last 6 months)
• •Active infection with HIV, Hepatitis B or Hepatitis C