RecruitingPHASE4INTERVENTIONAL

Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome

This study is investigating a side effect called ICANS that can sometimes happen after a powerful type of cancer treatment called CAR-T cell therapy. ICANS stands for Immune Effector Cell-Associated Neurotoxicity Syndrome, which means the brain and nervous system can be affected. Researchers believe that inflammation during treatment makes the barrier between the brain and blood leaky, releasing tiny particles called extracellular vesicles (EVs). EVs are like small messengers between cells. This study aims to track these EVs before and during CAR-T treatment, as well as when ICANS occurs. By doing this, alongside brain scans (MRI) and other tests, they hope to better understand why ICANS happens. Their ultimate goal is to find ways to prevent and treat this important side effect, which can affect how well patients recover.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrolment target

Start

02 Jul 2025

Estimated completion

01 Nov 2027

Immune Effector Cell Associated Neurotoxicity Syndrome

What is this study about?

This study, called VESICANS, is looking into a potential side effect of a modern cancer treatment called CAR-T cell therapy. CAR-T therapy is a very effective way to fight certain cancers, but sometimes it can lead to a condition called Immune Effector Cell-Associated Neurotoxicity Syndrome, or ICANS for short. This means that, in some cases, the brain and nervous system can be affected, which can be worrying for patients and their families.

We don't fully understand yet why ICANS happens, but scientists think that when the body reacts strongly to CAR-T cells to fight cancer, it can cause inflammation. This inflammation might affect the very important barrier that protects the brain from harmful substances in the blood. When this barrier becomes a bit leaky, tiny particles called extracellular vesicles (or EVs) might be released. These EVs are like microscopic packages that cells use to communicate with each other, and they might play a role in how ICANS develops.

In this study, researchers will carefully examine these EVs in patients receiving CAR-T therapy. They will collect samples before treatment, during treatment, and if ICANS occurs. They will use special techniques like flow cytometry and advanced microscopes to look at these EVs in detail. Alongside this, they will also use MRI scans to get detailed pictures of the brain and see how the brain's protective barrier is working. The main goal is to learn more about how and why ICANS happens, which could then help doctors develop better ways to prevent and treat it, ultimately improving the experience and outcomes for patients.

Key takeaways

This study investigates a brain-related side effect called ICANS, sometimes seen with CAR-T cell therapy.
It aims to understand how tiny cell messengers (EVs) are involved.
Data from the study could lead to better ways to prevent or treat ICANS in the future.
Participation involves extra blood tests and MRI scans during your CAR-T treatment.
You will still receive your standard CAR-T cell treatment.
Your decision to join or leave the study won't affect your medical care.

Who may be eligible?

To be part of this study, you need to be an adult over 18 years old. You must also be scheduled to receive CAR-T cell treatment for your condition, as decided by your doctors. It's important that you are covered by a social security system, which helps ensure your healthcare is looked after.

Crucially, you must be able to understand what the study involves and be happy to give your permission to take part. This is called ‘informed consent’ and means you've had all your questions answered and feel comfortable with the study.

There are also some reasons why you wouldn't be able to join. If you are pregnant or breastfeeding, the study isn't suitable for you. Also, if you are unable to understand the information about the study or are under legal protection that prevents you from making such decisions independently, you wouldn't be able to participate.

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?
Are you scheduled to have CAR-T cell treatment?
Are you able to understand the study information and give your permission to join?
Are you not pregnant or breastfeeding?
Are you covered by a social security system?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the researchers will collect samples of your blood at different times: before your CAR-T cell treatment, during the treatment process, and specifically if you show any signs of the side effect called ICANS. These blood samples will be used to look for the tiny particles (EVs) mentioned in the study. You will also have MRI scans, which are special pictures of your brain, to check on the barrier between your brain and blood vessels. Additionally, you may undergo some neuropsychological tests, which are like puzzles and questions to check how your brain is working, such as your memory and thinking skills. The exact number of visits and tests will depend on your individual treatment plan and whether ICANS develops. The total duration of your involvement will largely align with your CAR-T cell treatment and follow-up, and the specific schedule will be fully explained to you before you agree to participate.

Potential risks and benefits

Participating in this study might not directly benefit you, but the information gained could greatly help future patients by leading to better ways to prevent or treat ICANS. The risks typically involve the standard procedures for blood tests and MRI scans, which are generally safe but carry very small risks like bruising from blood draws or claustrophobia during an MRI. All your medical care related to your CAR-T treatment will continue as usual. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

CHU de Saint-Etienne
Verified postcode
Saint-Etienne, France· Recruiting

Common questions

What are CAR-T cells?

CAR-T cells are a special type of your own immune cells that have been modified in a lab to better find and destroy cancer cells in your body.

What is ICANS?

ICANS is a side effect that can sometimes happen with CAR-T cell therapy, where the brain or nervous system can be affected. It stands for Immune Effector Cell-Associated Neurotoxicity Syndrome.

What are 'extracellular vesicles'?

These are tiny packages released by cells that carry messages. Researchers think they might play a role in how ICANS develops.

Will I receive a different treatment if I join?

No, you will receive your CAR-T cell treatment as planned. This study is about understanding a side effect, not changing your main treatment.

Is an MRI scan safe?

Yes, MRI scans use strong magnets and radio waves to create pictures of your body. They don't use radiation and are generally safe for most people. The research team will check if an MRI is safe for you.

How to find out more

Emilie CHALAYER, MD

emilie.chalayer@chu-st-etienne.fr (0)4 77 82 28 14 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.