Helsinki University Central Hospital
Helsinki, Finland
Not recruiting
Study of Bexmarilimab Combined with Standard Treatment for Patients with Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia
Verified siteInvestigational
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This study focuses on three types of blood cancers: Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, and Acute Myeloid Leukemia. These conditions affect the body's ability to produce normal blood cells. The study will test a new medication called bexmarilimab (also known as FP-1305 or Clevegen) in combination with standard treatments that patients normally receive for these conditions.
The purpose of this research is to determine if bexmarilimab is safe to use alongside current treatments and to see how well it works in treating these blood cancers. The medication will be given to patients through intravenous infusion, which means it will be delivered directly into the bloodstream through a vein.
The study is divided into two parts. In the first part, researchers will determine the safest and most appropriate dose of bexmarilimab to use. In the second part, they will evaluate how effective this dose is when combined with standard treatments. Throughout the study, patients will be monitored for any side effects and their response to the treatment.
The research process
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
11 criteria
- Must be 18 years of age or older
- Must have one of the following confirmed conditions:
- Myelodysplastic Syndrome (MDS) with intermediate, high or very high risk according to revised scoring system
- Chronic Myelomonocytic Leukemia type 2 (CMML-2) requiring azacitidine treatment
- CMML or MDS that did not respond to previous therapy
- Acute Myeloid Leukemia (AML) that has returned or not responded after at least one previous treatment, requiring azacitidine
- AML in patients who cannot receive standard intensive chemotherapy and need azacitidine-venetoclax treatment
- Must have a white blood cell count less than:
- 20,000 cells per microliter for most patients
- 25,000 cells per microliter for newly diagnosed AML patients
- Must have normal kidney function
- Must have normal liver function
- Both men and women may participate
Who cannot join the trial?
15 criteria
- Age below 18 years
- History of severe allergic reactions or hypersensitivity to any medications
- Participation in other clinical trials within the last 30 days
- Active infections requiring treatment
- Pregnant or breastfeeding women
- Significant heart problems, including uncontrolled high blood pressure or recent heart attack (within 6 months)
- Severe liver problems (liver disease that affects its function)
- Severe kidney problems (kidney disease that affects its function)
- Active or untreated cancer other than those being studied in this trial
- Mental health conditions that could interfere with following study procedures
- Use of medications that could interact with the study drug
- Major surgery within 4 weeks before starting the study
- Compromised immune system due to HIV, AIDS, or other conditions
- History of organ transplantation
- Inability to provide informed consent
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Verified sites
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Verified Verified Kuopio University Hospital
Kuopio, FinlandVerified Oulu University Hospital
Oulu, Finland
Trial locations
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Investigated drugs
Bexmarilimab is an antibody medication that targets a protein called Clever-1. It is being studied as a new treatment option for blood disorders. This medication works with the body's immune system and is given in combination with standard treatments. It is being tested to help patients with certain types of blood cancers, including myelodysplastic syndrome, chronic myelomonocytic leukemia, and acute myeloid leukemia.
Standard of Care (SoC) therapy refers to the current best available treatments that are typically used for these blood disorders. The specific treatments may vary depending on the patient's condition and will be determined by their healthcare team.
What is already known about the treatment
Bexmarilimab - An investigational antibody medication administered intravenously that targets the Clever-1 protein and is currently being studied in clinical trials for the treatment of various blood disorders including Myelodysplastic Syndrome, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia. The drug belongs to the class of monoclonal antibodies and works by modulating the immune system's response through its interaction with Clever-1, a protein involved in immune cell regulation. This experimental therapy is being evaluated in combination with standard of care treatments to assess its safety, tolerability, and potential effectiveness in improving outcomes for patients with these challenging hematologic conditions.
Investigated diseases
Myelodysplastic Syndrome
A blood disorder where bone marrow fails to produce enough healthy blood cells. The condition occurs when blood-forming cells in the bone marrow become abnormal, leading to low levels of one or more types of blood cells. The abnormal cells can gradually increase over time, leaving less room for healthy blood cells.
Acute Myeloid Leukemia
A type of blood and bone marrow cancer that develops when young blood cells called myeloid cells fail to mature properly. These immature cells build up in the bone marrow and blood, preventing the production of normal blood cells. The disease progresses rapidly, affecting the production of red blood cells, white blood cells, and platelets.
Chronic Myelomonocytic Leukemia
A blood cancer that affects blood-forming cells in the bone marrow. The condition causes increased numbers of white blood cells called monocytes in the blood and bone marrow. It develops gradually and leads to reduced production of other normal blood cells over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517444-64-00Protocol codeFP2CLI004Estimated enrolment180 patientsSponsorFaron Pharmaceuticals Oy
sourced from the EU Clinical Trials Register and site verification
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