Age

18–any

Sex

ALL

Healthy volunteers

Not accepted

Adults ≥18 years of age (or ≥19 years of age according to local regulatory guidelines) at the time of signature of the informed consent form.
Documented diagnosis of relapsed or refractory AML with any detectable level of CD123 as evaluated by local assessment.
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Adequate organ and coagulation function.

Diagnosed with Acute Promyelocytic Leukemia.
Systemic antineoplastic agent therapy given within 14 days or 5 half-lives prior to the first dose of ORM-1153 (whichever is shorter).
Hematopoietic Stem Cell Transplantation within 3 months of the first dose of ORM-1153.
Total White Blood Cell count \>25,000/µL.

Study of ORM-1153 in Acute Myeloid Leukemia (AML) With CD123 Expression