A phase 2 immunoPET imaging study with ZED88082A/CED88004S in patients with large B-cell lymphoma before and after CD19-directed CAR T-cell therapy
This study is for people with large B-cell lymphoma. We are using a special type of scan, called a PET scan, with a unique tracing substance (ZED88082A/CED88004S) to help us understand more about this cancer. The main goal is to see how this substance spreads throughout the body, both in healthy areas and in the cancer, before and after patients receive a treatment called CAR T-cell therapy. By doing this, we hope to learn how well the cancer takes up this substance, which might give us clues about how the new CAR T-cell therapy is working and potentially spot any side effects. This information could help doctors in the future to better understand and treat large B-cell lymphoma.
At a glance
What is this study about?
This study is designed to help us understand more about a type of cancer called large B-cell lymphoma and how a new treatment, CAR T-cell therapy, affects it. Think of it like taking a special picture of your body to see where the cancer is and how it's changing with treatment.
We're using a special substance, often called a 'tracer' (ZED88082A/CED88004S), which is given to you before a scan called a PET scan. This tracer helps parts of your body, including the cancer, light up on the scan. By looking at these scans before and after you have CAR T-cell therapy, doctors can see how the treatment is affecting the cancer and how the tracer moves around in your body.
We also want to check for any links between how well the cancer takes up this tracer, specific marks found in cancer samples (biopsies), and how well the CAR T-cell therapy works. We'll also be looking at how the CAR T-cells behave in your blood and if there are any side effects from the therapy. This research is really important because it could help us develop better ways to monitor and treat large B-cell lymphoma in the future.
Key takeaways
- This study uses a special scan to track large B-cell lymphoma.
- It helps understand how CAR T-cell therapy affects the cancer.
- A tracer substance will be used with PET scans.
- Researchers will check for links between scans, biopsies, and treatment success.
- Safety is a key focus, monitoring for any side effects.
Who may be eligible?
This study is looking for adults aged 18 and over, of any gender, who have been diagnosed with large B-cell lymphoma.
To make sure the study is safe and effective for everyone involved, there will be certain health checks and requirements you'll need to meet. For example, your general health will be assessed to ensure you can safely take part in the scanning procedures and any related treatments.
- Are you 18 years old or older?
- Do you have large B-cell lymphoma?
- Are you able to have PET scans?
- Are you considering or receiving CD19-directed CAR T-cell therapy?
- Are you generally well enough to participate in a clinical study?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you will have several appointments involving PET scans. For these scans, you'll receive a small amount of the special tracer substance (ZED88082A/CED88004S) as an injection. The scan will usually take place about two days after this injection. These scans will happen both before you start your CAR T-cell therapy and again after you've had it.
You'll also have blood tests and, if needed, some tissue samples taken (biopsies) to check for certain markers related to your cancer and the treatment. The study team will monitor your health closely throughout the process, including looking for any side effects from the CAR T-cell therapy or the tracer. The overall duration of your participation will depend on your treatment plan and how long you are followed up by the study team.
Potential risks and benefits
Locations (1)
- —Netherlands
Common questions
What is large B-cell lymphoma?
It's a type of cancer that starts in white blood cells called lymphocytes, which are part of your immune system.
What is CAR T-cell therapy?
It's a treatment where your own immune cells are modified to better fight your cancer.
What is a PET scan?
It's a special type of scan that uses a small amount of a radioactive tracer to show how organs and tissues are working.
Will I have to pay to be in this study?
No, all study-related treatments and tests will be provided at no cost to you.
What if I change my mind about participating?
You can withdraw from the study at any time, for any reason, without it affecting your medical care.
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.