A study to investigate safety of INT2104 infusions in participants aged 18 years of age and older who have B-cell cancers that came back after previous treatment [INVISE]
This study, called INVISE, is investigating a new medication, INT2104, for adults aged 18 and over who have certain B-cell cancers. These are cancers that affect a type of white blood cell and have either come back after earlier treatment or didn't respond to it. This is a very early stage (Phase I) study, meaning it's one of the first times this treatment is being given to people. The main goal is to see how safe INT2104 is. Researchers will be giving different doses of the treatment to understand any side effects and how the body handles it. This kind of research is crucial for developing potential new ways to fight cancer.
At a glance
What is this study about?
Imagine your body's immune system has special cells called B-cells. Sometimes, these B-cells can become cancerous, leading to a type of cancer called B-cell malignancy. For some people, these cancers can be difficult to treat, returning even after initial treatments or not responding as hoped. This is called 'relapsed' or 'refractory' cancer.
This study, named INVISE, is exploring a new treatment called INT2104. It's designed for adults aged 18 and over who have these specific B-cell cancers that have come back or haven't gotten better with previous therapies. Think of INT2104 as a new tool that researchers hope might help fight these challenging cancers. Because this is an early study (what doctors call 'Phase I'), the main focus is on carefully checking its safety in people for the very first time.
Doctors need to understand if a new medicine is safe before they can test how well it works. By carefully giving INT2104 to a small group of people and closely watching them, the research team can learn a lot about possible side effects and how the body handles the treatment. This information is a vital first step in developing promising new treatments for cancer patients in the future.
Key takeaways
- This study is testing a new drug (INT2104) for B-cell cancers that have come back or not responded to prior treatments.
- It's a 'Phase I' study, so the main goal is to check how safe it is for people.
- Anyone aged 18 or older with the specific cancer type can be considered.
- Participation involves receiving the drug via infusion and having regular checks.
- You have the right to leave the study at any time.
- Doctors will closely monitor you for safety and side effects.
Who may be eligible?
This study is looking for adults aged 18 and over. It's important that you have a B-cell cancer that has either come back after you've had treatment before, or didn't get better with previous treatments. Both men and women can take part.
Because this is a very early study, there will likely be other requirements to make sure it's safe for you to participate. For example, your doctors will need to check your general health, blood tests, and how well your organs are working. They'll also review your medical history carefully.
It's possible that if you have other serious health problems, are taking certain medications, or have recently had other treatments, you might not be able to join. The study team will go through all these details with you thoroughly to see if this study is a good fit for your situation.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Am I 18 years old or older?
- Do I have a B-cell cancer?
- Has my cancer come back after earlier treatment or not responded to it?
- Am I generally well enough to consider a new treatment?
What does participation involve?
If you decide to take part, you would receive the study drug, INT2104, as an infusion (given directly into your bloodstream, usually through a drip). The study team hasn’t said exactly how many visits you would need or for how long, but generally, in early studies like this, you can expect quite frequent visits to the clinic or hospital, especially at the beginning.
These visits will involve various tests, such as blood tests, physical examinations, and possibly scans, to monitor your health and how your body is reacting to the treatment. The study doctors and nurses will closely watch you for any side effects. You will be told the total duration of your participation and what happens after you finish receiving the treatment.
Potential risks and benefits
Locations (2)
- —UnverifiedSpain
- —UnverifiedGermany
Common questions
What does a 'Phase I' study mean?
It means this is one of the first times this new treatment is being given to people. The main goal is to make sure it's safe and to see how the body handles it, rather than primarily checking how well it works yet.
What kind of cancer is this study for?
It's for specific B-cell cancers (a type of white blood cell cancer) that have either come back after previous treatment or have not responded well to past treatments.
Will this treatment cure my cancer?
This early study is focused on safety. While some people might see their cancer improve, it's not designed to prove if it's a cure. This comes in later stages of research.
Will I have to pay to be in the study?
No, you will not have to pay for the study treatment or for procedures directly related to the study. Travel costs might be covered, but you should ask the study team about this.
Can I continue my usual medications while on the study?
This will depend on your specific medications and what the study allows. It's very important to tell the study team about all medicines, supplements, and anything else you are taking.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.