Study of MP0533 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Inclusion Criteria: Has signed and dated written informed consent prior to performing any study procedure, including screening Diagnosis of AML or MDS/AML according to the ELN, refractory or relapsed to pretreatment with hypomethylating agents (HMA) (with or without venetoclax), induction chemotherapy or allogeneic hematopoietic cell transplantation (HCT) Age ≥18 years old on the day of signing informed consent Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2 Anticipated life expectancy ≥ 12 weeks by investigator judgement Adequate renal and hepatic function: Is using highly effective contraception, for females of childbearing potential and for men Exclusion Criteria: Allogeneic HCT within the last 3 months Active GvHD requiring immune-suppressive therapy Use of immunosuppressive drugs Symptoms of leukostasis (prior hydroxyurea allowed) Clinical signs of AML in the central nervous system Major surgery within 28 days prior to start of study medication Other malignancy requiring active therapy, but adjuvant endocrine therapy is allowed Any active infection requiring the use of parenteral antimicrobial agents or that is grade >2 Treatment with investigational agents and/or agents targeting CD33, CD123 or CD70 within 4 weeks prior to start of trial medication Left ventricular ejection fraction of < 50% on echocardiographic exam at screening History or evidence of clinically significant cardiovascular disease Pulmonary disease with clinically relevant hypoxia Concurrent enrolment in another clinical trial, unless it is an observational (non-interventional) study or it is the follow-up period of an interventional study Known hypersensitivity to any of the excipients of the investigational medicinal product (IMP), i.e. finished MP0533 drug