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

• Status: Recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Molecular Partners AG

Criteria

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