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A study of MP0533 in patients with blood cancer.
EU CTIS ID: 2023-505259-39-00
What this study is testing
Investigating MP0533 as monotherapy in patients with R/R AML and MDS/AML is to: - Determine the safety and tolerability - Define the recommended phase 2 dose regimen (RP2D-R) and/or the maximum tolerated dose-regimen (MTD-R) (phase 1 only) - Evaluate the preliminary anti-leukemic activity (primary for phase 2a, secondary for phase 1)
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has signed and dated written informed consent prior to performing any study procedure, including screening
- Diagnosis of relapsed/refractory AML or relapsed/refractory MDS/AML according to the ELN recommendation 2022
- 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: a. Creatinine clearance > 40 mL/min on the basis of Cockcroft-Gault glomerular filtration rate estimation, unless considered AML- or MDS-related b. Serum bilirubin ≤ 2.5 x upper limit of normal (ULN), unless considered AML- or MDS-related or due to Gilbert’s syndrome c. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN, unless considered AML- or MDS-related
You likely can't join if
- Mixed phenotype acute leukemia
- Major surgery within 28 days prior to start of study medication
- Other malignancy requiring active therapy, but adjuvant endocrine therapy is allowed
- Left ventricular ejection fraction of < 50% on echocardiographic exam at screening
- Any uncontrolled active infection
- Treatment with investigational agents or agents targeting CD33, CD123 or CD70 within 4 weeks or five times the half-life of the agent, whichever is longer, prior to start of trial medication
See the full eligibility criteria
Who can join
- Has signed and dated written informed consent prior to performing any study procedure, including screening
- Diagnosis of relapsed/refractory AML or relapsed/refractory MDS/AML according to the ELN recommendation 2022
- 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: a. Creatinine clearance > 40 mL/min on the basis of Cockcroft-Gault glomerular filtration rate estimation, unless considered AML- or MDS-related b. Serum bilirubin ≤ 2.5 x upper limit of normal (ULN), unless considered AML- or MDS-related or due to Gilbert’s syndrome c. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN, unless considered AML- or MDS-related
- White blood count (WBC) ≤ 15G/L at day of trial drug infusion (prior hydroxyurea allowed)
- Is using highly effective contraception, for females of childbearing potential (FCBP) and for men.
What rules you out
- Mixed phenotype acute leukemia
- Major surgery within 28 days prior to start of study medication
- Other malignancy requiring active therapy, but adjuvant endocrine therapy is allowed
- Left ventricular ejection fraction of < 50% on echocardiographic exam at screening
- Any uncontrolled active infection
- Treatment with investigational agents or agents targeting CD33, CD123 or CD70 within 4 weeks or five times the half-life of the agent, whichever is longer, prior to start of trial medication
- History or evidence of clinically significant cardiovascular disease defined as at least one of the following criteria: Evidence of poorly controlled arterial hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg); Myocardial infarction or unstable angina pectoris within 6 months before screening; Heart failure (New York Heart Association Class III or IV); Any cardiac arrhythmia that is not well controlled; QT corrected (QTc) prolongation ≥ Grade 2 (> 480 ms) at screening measured on 2 separate electrocardiograms (ECG) at least 10 minutes apart; Clinically significant valvular heart disease
- Pulmonary disease with clinically relevant hypoxia (need for continuous oxygen inhalation)
- Known Human Immunodeficiency Virus (HIV)-infected patients who are healthy and have a low risk of Acquired Immunodeficiency Syndrome (AIDS)-related outcomes are eligible, if: No history of AIDS-defining opportunistic infection within past 12 months; Patient agrees to concomitant antiretroviral therapy (ART) if not currently on ART, is on ART for ˃ 4 weeks and has a HIV viral load ˂ 400 copies/mL
- Active hepatitis.
- Any vaccines within 28 days before first study drug administration
- Allogeneic HCT within the last 3 months prior to start of trial medication and/or eligibility for standard 2nd line of targeted therapy, like gilteritinib for FLT3 mutated AML, unless this therapeutic option has already been given and proven ineffective (patient relapsed or resistant to), or contraindicated, or confounding mutations exist, or there is a lack of access to this recommended therapy.
- History of another primary malignancy except for: Malignancy treated with curative intent and with no known active disease ≥ 2 years before screening and of relatively low potential risk for recurrence; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of residual disease; Adequately treated carcinoma in situ without evidence of disease; Cancer patients with incidental histologic findings of prostate cancer that, in the opinion of the investigator, is not deemed to require active therapy may be eligible, pending discussion and approval by the Sponsor
- Concurrent enrollment in another clinical trial, unless it is an observational (noninterventional) study or it is the follow-up period of an interventional study
- Patients with favorable AML mutations according to ELN recommendation 2022 and 2024.
- More than 2 prior lines of anti-leukemic therapy.
- Known hypersensitivity to any of the excipients of the investigational medicinal product (IMP), i.e. finished MP0533 drug
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the IMP or interpretation of the patient’s data
- Unable or unwilling to comply with all study requirements for clinical visits, examinations, tests and procedures, and contraception requirements
- Patient deprived of liberty by a judicial or administrative decision, patient admitted to a social institution or who is under a measure of legal protection, patient hospitalized without consent or who is in an emergency
- Active GvHD requiring immune-suppressive therapy (other than prednisone (or equivalent) ≤ 10mg/d)
- Use of immunosuppressive drugs (other than prednisone (or equivalent) ≤10mg/d) in the past 4 weeks
- Clinical signs of AML in the central nervous system
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.