Overview
The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of MP0533 in patients with relapsed/refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
Eligibility
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