Actively Recruiting
Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome
Led by Molecular Partners AG · Updated on 2025-09-30
249
Participants Needed
9
Research Sites
361 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of MP0533 in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
CONDITIONS
Official Title
Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any study procedures
- Diagnosis of relapsed or refractory AML or MDS/AML according to ELN 2022 recommendations
- Age 18 years or older at consent
- ECOG performance status 0 to 2
- Life expectancy of at least 12 weeks as judged by investigator
- White blood count 15 G/L or less on day of trial drug infusion
- Adequate kidney and liver function
- Using highly effective contraception if female of childbearing potential or male
You will not qualify if you...
- Mixed phenotype acute leukemia
- Favorable AML mutations per ELN 2022 and 2024
- Allogeneic hematopoietic cell transplant within last 3 months or eligibility for standard second-line therapy unless ineffective or contraindicated
- More than 2 prior anti-leukemic treatment lines
- Active graft-versus-host disease needing immune-suppressive treatment
- Use of immunosuppressive drugs
- Signs of AML in central nervous system
- Major surgery within 28 days before study medication start
- Other cancers needing active therapy except adjuvant endocrine therapy
- Any uncontrolled active infection
- Treatment with investigational agents or agents targeting CD33, CD123, or CD70 within 4 weeks or five times the agent's half-life prior to study
- Left ventricular ejection fraction below 50%
- Significant cardiovascular disease history or evidence
- Lung disease causing relevant hypoxia
- Active hepatitis
- Concurrent participation in another interventional clinical trial
- Known allergy to study drug ingredients
- For dose expansion arm: prior venetoclax treatment, recent CYP3A inducer use, recent consumption of grapefruit or similar fruits, malabsorption or inability to take oral venetoclax
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
CHU Bordeaux
Bordeaux, France
Actively Recruiting
2
AP-HP Hôpital Saint-Louis
Paris, France, 75010
Actively Recruiting
3
IUCT Oncopole
Toulouse, France
Actively Recruiting
4
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
Actively Recruiting
5
Groningen UMC
Groningen, Provincie Groningen, Netherlands
Actively Recruiting
6
Amsterdam UMC - Locatie VUmc
Amsterdam, Netherlands
Actively Recruiting
7
Erasmus MC
Rotterdam, Netherlands
Actively Recruiting
8
Inselspital, Universitaetsspital Bern
Bern, Canton of Bern, Switzerland, 3010
Actively Recruiting
9
Universitaetsspital Zuerich
Zurich, Canton of Zurich, Switzerland, 8006
Actively Recruiting
Research Team
M
Medical Director MPAG
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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