Study of Bexmarilimab Combined with Standard Treatment for Patients with Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia

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What is this study about?

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.

1 Initial treatment phase

You will receive bexmarilimab (Clevegen) through an intravenous infusion (delivered directly into your vein) in combination with your standard treatment.

Your standard treatment will depend on your specific condition – either myelodysplastic syndrome, chronic myelomonocytic leukemia, or acute myeloid leukemia.

2 Safety monitoring

During treatment, your doctor will monitor your health closely for any side effects or reactions to the medication.

Regular blood tests will be performed to check your kidney and liver function.

Your white blood cell count will be monitored to ensure it stays below required levels.

3 Response evaluation

Your doctor will assess how well the treatment is working by checking your response to the therapy.

The assessment will include specific tests depending on your condition to measure the effectiveness of the treatment.

4 Ongoing monitoring

Throughout the study period (until June 2025), your health status will be regularly evaluated.

Blood samples will be collected at specific times to measure drug levels in your body.

Tests will be conducted to check if your body has developed antibodies to the study medication.

Who Can Join the Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Kuopio University Hospital	Kuopio	Finland

Other Sites

Site Name	City	Country
Oulu University Hospital	Oulu	Finland
Pirkanmaan hyvinvointialue	Tampere	Finland
Hqbxfcwk Uwuszjcizh Cuhuqri Hofjzgtn	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not recruiting	01.06.2022

Trial locations

Investigated drugs:

Bexmarilimab

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.

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 ID:

2024-517444-64-00

Protocol code:

FP2CLI004

NCT ID:

NCT05428969

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Bexmarilimab Combined with Standard Treatment for Patients with Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?