IO-202 as Monotherapy and IO-202 Plus Azacitidine ± Venetoclax in Patients in AML and CMML

Exclusion Criteria

• •1. Patients who have previously received a monoclonal antibody therapy targeting LILRB4.
• •2. Patients who have undergone HSCT within 60 days of the first dose of IO-202.
• •3. Patients who received systemic anti-cancer therapy or radiotherapy \<7 days prior to their first day of study drug administration (Hydroxyurea or leukapheresis is allowed up to 24 hours prior to the first dose.
• •4. Patients who received an investigational agent \<7 days prior to their first day of study drug administration.
• •5. Patients for whom potentially curative anti-cancer therapy is available.
• •6. Patients who are pregnant or breastfeeding.
• •7. Patients with uncontrolled, active infection.
• •8. Patients with known hypersensitivity to any of the components of the IO-202 formulation.
• •9. Patients with known pulmonary lesions and/or history of pneumonitis or interstitial lung disease.
• •10. Active known malignancy.
• •11. Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF) or left ventricular ejection fraction (LVEF) \<40%.
• •12. Ongoing cardiac dysrhythmias Grade 2 or higher per of NCI CTCAE, Version 5.0, Grade ≥2.
• •13. Known or suspected hypersensitivity to recombinant proteins.
• •14. Known active bacterial, viral, and/or fungal infection.
• •15. Patients with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol.
• •16. Patients with clinical signs and/or symptoms suggesting active, uncontrolled central nervous system (CNS) leukemia or known active, uncontrolled CNS leukemia.
• •17. Patients with immediately life-threatening, severe complications of leukemia.
• •18. Donor Lymphocyte Infusion within 30 days prior to first IO-202 administration.
• •19. Current active treatment in another interventional therapeutic clinical study.
• •20. Chronic systemic corticosteroid treatment with a dose of \>10 mg prednisone/day or dose equivalent.
• •21. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
• •22. Acute Promyelocytic Leukemia patients or patients with known Philadelphia chromosome (Ph+) positive AML or chronic myelogenous leukemia (CML) blast crisis.
• •23. Hyperleukocytosis (leukocytes ≥25 x 10e9/L) at first dose of IO-202.