Investigating infection risk and the microbiome in blood cancer patients treated with CD19 CAR-T therapy
This study investigates infections in adults with a type of blood cancer called B-cell lymphoma, who are undergoing a new, advanced treatment called CAR-T therapy. CAR-T therapy uses a patient's own immune cells to fight cancer, but it can make them vulnerable to infections for a long time. The research aims to find out how common infections are after CAR-T, which patients are at highest risk, and what germs cause them. It will also explore the role of the 'microbiome' – the collection of tiny living things like bacteria in our bodies, especially in the gut and nose – in infection risk and treatment success. Understanding this could help improve ways to prevent and treat infections for future CAR-T patients.
At a glance
What is this study about?
Blood cancer patients often have a weakened immune system, which makes them more likely to get infections. This study focuses on people with a type of blood cancer called B-cell lymphoma who are receiving a special type of treatment called CAR-T therapy. This is a very advanced treatment where a patient's own immune cells are re-trained to find and destroy cancer cells. While CAR-T therapy can be very effective, it can also leave patients vulnerable to infections like flu, COVID-19, and common bacteria for a long time afterwards.
This research aims to get a better understanding of these infections. We want to find out how often they occur after CAR-T treatment, what kinds of infections they are, and which patients are most likely to get them. We'll also be looking at the 'microbiome', which refers to all the tiny living things (like bacteria) that naturally live in and on our bodies, particularly in the gut and nose. We know the microbiome plays a big role in our general health, but its specific impact on CAR-T patients and their infection risk isn't fully understood. By studying this, we hope to learn more about how the microbiome affects both infection risk and how well patients recover from their cancer treatment.
Ultimately, the goal of this study is to gather important information that could help doctors better prevent and treat infections in patients receiving CAR-T therapy in the future. This could lead to safer and more successful outcomes for people battling blood cancer.
Key takeaways
- A study looking at infections after CAR-T therapy for blood cancer.
- Aims to understand infection risks and the role of the body's 'microbiome'.
- Involves providing nose swabs, poo samples, and blood samples over one year.
- Participation will not change your cancer treatment.
- Helps improve care for future CAR-T patients by understanding infection prevention.
- Small Amazon voucher provided, but no direct health benefits for participants.
Who may be eligible?
This study is looking for adults aged 18 or over who have been diagnosed with a type of blood cancer called high-grade B-cell lymphoma and are planning to have CAR-T cell therapy. You need to be able to understand the study and agree to take part.
There are a few reasons why someone might not be able to join. For example, if you are under 18, pregnant, or currently in prison, you wouldn't be able to participate. Also, if you've had a type of stem cell transplant from another person in the past, or if you have certain ongoing nose problems like frequent nosebleeds, nasal polyps, or recently had nose surgery or a broken nose, you might not be eligible. This is mainly because the study involves taking nose swabs, and we need to make sure this is safe for you.
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.
- Are you 18 years old or older?
- Do you have high-grade B-cell lymphoma?
- Are you about to start CD19 CAR-T therapy?
- Do you feel you can understand the study information and agree to take part?
- Do you have any ongoing nose problems (e.g., frequent nosebleeds, polyps, recent surgery/broken nose)? If yes, you might not be eligible.
- Have you had a stem cell transplant from another person?
What does participation involve?
If you decide to take part, the study will follow you for about one year after your CAR-T therapy begins. During this time, the researchers will collect information and samples to understand your infections, your recovery from CAR-T treatment, and your microbiome.
This involves collecting some samples at specific times: before you start CAR-T therapy, about 7-14 days after receiving the CAR T-cells, and then again around 3-4 months later. These samples will include a nose swab (taken from the front of your nose, similar to a COVID-19 test), a stool (poo) sample, and a blood sample. You will also be asked to provide additional samples if you are admitted to hospital during the follow-up period regarding an infection.
Additionally, you will be asked to collect your own nose swabs at home and fill out a short questionnaire whenever you experience cold or flu-like symptoms. You'll receive envelopes to post these samples back to the study team. You might also be asked to provide a repeat nose swab and questionnaire one week later for each of these illness episodes. The study will also collect information from your medical records and through direct questions.
Potential risks and benefits
Locations (3)
- Cambridge University Hospitals NHS Foundation TrustUnverifiedCambridge, England
- Oxford University Hospitals NHS Foundation TrustUnverifiedOxford, England
- University Hospitals Birmingham NHS Foundation TrustUnverifiedBirmingham, England
Common questions
What is CAR-T therapy?
CAR-T therapy is a new, advanced treatment for some blood cancers where your own immune cells are specially trained to find and destroy cancer cells.
What is the microbiome?
The microbiome is the collection of all the tiny living things, like bacteria, that naturally live in and on your body, especially in your gut and nose.
Will I get my results?
No, individual results from your samples will not be given back to you as they are for research purposes only and not for diagnosing or monitoring your health.
Will taking part change my treatment?
No, this is an observational study, which means your medical treatment will not be changed in any way by taking part.
Who is funding this research?
The main funder is Blood Cancer UK, with additional support from the National Institutes of Health and Care Research (NIHR) and the Wellcome Sanger Institute.
How to find out more
William Hamilton
Always speak to your GP or specialist before deciding to take part in a study.
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