A Phase I/II Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of the Clever-1 Antibody Bexmarilimab in Combination with Standard of Care Therapy in Patients with Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia or Acute Myeloid Leukemia (BEXMAB Study)
This research study is looking at a new treatment called bexmarilimab for adults with certain blood cancers: Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), and Acute Myeloid Leukemia (AML). The main goal is to find out if bexmarilimab is safe when given alongside standard cancer treatments. Researchers will also be checking for any side effects and seeing how well patients tolerate the new drug. Additionally, the study will look to see if bexmarilimab helps improve the condition of people with these cancers. This study includes two phases: an early phase to check safety and dosage, and a later phase to further assess how well the treatment works.
At a glance
What is this study about?
This study is investigating a new medicine named bexmarilimab for people diagnosed with specific types of blood cancers: Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), and Acute Myeloid Leukemia (AML). These conditions affect the way your body makes healthy blood cells.
The main purpose of this research is to see if bexmarilimab can be safely given together with current standard treatments for these cancers. Researchers will carefully watch participants for any side effects and learn about the best dose to use. They will also collect information on how the new drug moves through the body and how the body reacts to it.
Beyond safety, the study will also explore whether bexmarilimab helps to improve the cancer for patients. For example, they will look at whether the cancer goes into remission (meaning signs of the cancer disappear or reduce significantly) or if it helps patients live longer or stop the disease from getting worse. This information is important for understanding if bexmarilimab could be a useful new treatment option in the future.
Key takeaways
- This study is testing a new drug called bexmarilimab for specific blood cancers.
- It aims to understand if bexmarilimab is safe and if it helps patients get better.
- The drug will be given alongside standard cancer treatments.
- The study includes adults aged 18 and over.
- Regular health checks and blood tests will be part of participating.
- You can stop participating at any time if you wish.
Who may be eligible?
To be part of this study, you must be at least 18 years old. Both men and women are welcome to participate.
Since this study focuses on specific blood cancers, you would need to have a diagnosis of Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML) to be considered for participation.
The research team will review your complete medical history and current health to make sure this study is the right fit for you and that taking part would be safe.
- Are you 18 years old or older?
- Do you have a diagnosis of Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)?
- Are you able to attend regular clinic appointments for treatment and check-ups?
- Are you willing to receive an experimental drug in combination with your current cancer treatment?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you will receive doses of the new medicine, bexmarilimab, along with your usual cancer treatment. You would have regular visits to the clinic for health checks, blood tests, and to make sure the treatment is safe and effective for you. These tests help the doctors understand how you are responding to the bexmarilimab and if you are experiencing any side effects.
The study involves both single and repeated doses of bexmarilimab, which means you would likely have a series of treatments over a period of time. Doctors will also check for any antibodies your body might make against bexmarilimab, which helps them understand how your immune system is reacting to the drug. The total length of your participation would depend on how your treatment progresses and the specific part of the study you are in.
Potential risks and benefits
Locations (1)
- —Finland
Common questions
What is bexmarilimab?
Bexmarilimab is a new experimental drug being tested to treat certain blood cancers.
What cancers is this study for?
This study is for people with Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML).
What does 'Phase I/II' mean?
Phase I is to check the drug's safety and find the right dose. Phase II looks more closely at how well the drug works and its effects.
Will I still get my usual treatment?
Yes, bexmarilimab will be given in combination with your standard cancer treatment.
Can I leave the study if I change my mind?
Yes, you are free to leave the study at any point without it affecting your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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