The CD33xCD123xCD70 Multispecific CD3-Engaging DARPin MP0533 Induces Selective T Cell-Mediated Killing of AML Leukemic Stem Cells.
Matteo Bianchi, Christian Reichen, Amelie Croset...
https://pubmed.ncbi.nlm.nih.gov/38683145Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID05673057
A Phase 1/2a First-in-human Open-label Multicenter Dose Escalation Study of MP0533 in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Led by Molecular Partners AG · Updated on 2025-09-30
249
Participants Needed
9
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MP0533, a multispecific DARPin CD3 engager targeting CD33, CD123, and CD70, in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). This study aims to assess the safety, tolerability, and early activity of MP0533 in these conditions. The trial includes both relapsed/refractory and treatment-nafve patients, exploring different dosing strategies and combinations with other drugs. Participants receive MP0533 through intravenous infusion in various study arms. Some groups receive MP0533 alone, while others receive it combined with azacitidine given as a subcutaneous injection for seven days per cycle and venetoclax taken orally for 14 days per cycle. An optional pretreatment with obinutuzumab is also part of some treatment plans. The study involves dose escalation and dose expansion phases to determine the best dosing regimen. During the trial, patients are closely monitored through blood tests and clinical evaluations to assess response and safety. Researchers measure outcomes including the recommended dose, overall response rate, serum drug levels, adverse events, survival outcomes, transfusion independence, and the number of patients proceeding to stem cell transplantation. The study typically follows participants for about one year, with some outcomes tracked for up to three years, to gather comprehensive data on treatment effects and safety.
CONDITIONS
Brief Title
Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed informed consent prior to any study procedure
- Diagnosis of relapsed or refractory AML or MDS according to ELN 2022 recommendations
- Age 18 years or older at consent
- ECOG performance status 0 to 2
- Anticipated life expectancy of at least 12 weeks
- White blood count 15 G/L or less on day of drug infusion
- Adequate kidney and liver function
- Use of highly effective contraception for females of childbearing potential and men
You will not qualify if you...
- Mixed phenotype acute leukemia
- Favorable AML mutations per ELN 2022 and 2024
- Allogeneic hematopoietic cell transplantation within last 3 months
- Eligibility for standard second-line targeted therapy unless already given and ineffective or contraindicated
- More than 2 prior lines of anti-leukemic therapy
- Active graft-versus-host disease requiring immunosuppressive therapy
- Use of immunosuppressive drugs
- Clinical signs of AML in the central nervous system
- Major surgery within 28 days before study medication
- Other malignancy needing active therapy (except adjuvant endocrine therapy)
- Uncontrolled active infection
- Treatment with investigational agents targeting CD33, CD123, or CD70 within 4 weeks or five times half-life prior to trial
- Left ventricular ejection fraction below 50%
- Clinically significant cardiovascular disease
- Pulmonary disease with relevant hypoxia
- Active hepatitis
- Concurrent enrollment in another clinical trial except observational or follow-up
- Known allergy to MP0533 ingredients
- For Arm B treatment-nafve patients: prior venetoclax treatment, recent use of strong/moderate CYP3A inducers, consumption of grapefruit or related products within 3 days before azacitidine/venetoclax, malabsorption or inability to take venetoclax orally
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive MP0533 and may receive additional medications such as obinutuzumab, azacitidine, and venetoclax depending on their assigned treatment arm. Treatments involve intravenous infusions, subcutaneous injections, and oral medications administered in cycles.
Weekly visits for treatment administration and monitoring
Follow-up
Duration - Up to 3 years
Participants are monitored for safety, treatment response, and long-term outcomes after completing treatment.
Approximately quarterly visits for up to 3 years
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
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Research Team
M
Medical Director MPAG
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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