Active not recruitingPHASE1INTERVENTIONAL

Immunotherapy Using CAR T-cells to Target CD19 for Relapsed/Refractory CD19+ Primary CNS Lymphoma

The CAROUSEL trial is looking at a new treatment called CAR T-cell therapy for adults (aged 16 and over) who have a specific type of brain lymphoma called Primary CNS Lymphoma. This is for people whose cancer has either come back after treatment or hasn't responded to their current treatment. This study is the first stage (Phase 1), focusing on whether it's possible to create this special cell therapy and if it's safe for patients. Researchers will also be watching to see how these special cells behave in the body, such as how long they last and how well they grow. This trial is hoping to find new ways to help patients with this challenging condition.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

University College, London

Enrolment target

Start

23 Mar 2021

Estimated completion

01 Dec 2032

Primary CNS Lymphoma

What is this study about?

The CAROUSEL trial is testing a new and advanced treatment called CAR T-cell therapy for a type of cancer that starts in the brain or spinal cord, known as Primary CNS Lymphoma. This is for adults whose cancer has either returned after previous treatment or hasn't responded as expected. This trial is an important first step (a Phase 1 study) in understanding this treatment. It aims to see if we can successfully create this special cell therapy for each patient, if it's safe to use, and how well the treatment cells settle and work in the body.

CAR T-cell therapy involves taking some of your own immune cells, called T-cells, and specially modifying them in a laboratory. These modified T-cells are then given back to you. They are designed to recognise and fight the cancer cells more effectively. This trial is particularly interested in targeting a specific marker on the cancer cells called CD19, to help the new T-cells find them.

This research is really important because Primary CNS Lymphoma can be difficult to treat, especially when it comes back or doesn't respond to standard therapies. By carefully studying this new approach, doctors hope to find better ways to help patients in the future.

Key takeaways

Tests a new CAR T-cell therapy for brain lymphoma.
For adults whose lymphoma has returned or hasn't responded.
Focuses on safety and how the treatment works in the body.
Involves collecting your own immune cells for modification.
Requires a hospital stay for monitoring after treatment.
Long-term follow-up for two years to track progress and health.

Who may be eligible?

This study is for adults aged 16 or older who have been diagnosed with Primary CNS Lymphoma. Your lymphoma must have CD19 on its surface (doctors will test for this). It also needs to be a type that has either come back after treatment or hasn't responded well to previous treatments.

There are certain health conditions or past treatments that would mean you couldn't join. For example, if you have other types of severe infections, significant heart problems, or certain autoimmune diseases, this study might not be suitable. Women who are pregnant or breastfeeding cannot take part. Your doctor will carefully review all your medical information to see if this trial is right for you, and whether you are healthy enough for the procedures involved.

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 16 years old or older?
Do you have Primary CNS Lymphoma that has come back or not responded to treatment?
Has your doctor confirmed your lymphoma has the CD19 marker?
Are you able to undergo various medical procedures?
Are you not currently pregnant or breastfeeding (if applicable)?

Answer every question to see your result.

What does participation involve?

If you join the study, doctors will first collect some of your blood to get your T-cells. This process is called 'leukapheresis' and is similar to donating blood, but takes a bit longer. While your special CAR T-cells are being prepared in the lab (which takes about 15 days), you might receive some 'holding' chemotherapy to keep your cancer in check.

Before you receive your CAR T-cells, you'll have some chemotherapy for a few days to prepare your body. Then, you'll receive the CAR T-cells through a drip into your vein. Doctors will monitor you very closely in the hospital for about 2-4 weeks after this. After leaving the hospital, you'll have regular check-ups for two years: monthly for the first six months, then every six weeks until a year, and then every three months until two years after your treatment.

Potential risks and benefits

Being part of this trial could offer the potential benefit of trying a new treatment that might help if other therapies haven't worked for your lymphoma. However, it's important to remember that this is a new type of therapy, and there could be side effects, some of which might be serious. Your doctors will explain all known risks. Participating in a trial means you'll have very close medical monitoring. You have the full right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University College London Hospital
Verified postcode
London, United Kingdom

Common questions

What is Primary CNS Lymphoma?

It's a rare cancer that starts in the brain or spinal cord, which are parts of your central nervous system.

What is CAR T-cell therapy?

It's a treatment where your own immune cells are specially trained to find and destroy cancer cells.

What does 'relapsed/refractory' mean?

It means your cancer has either come back after treatment or hasn't responded to previous treatments.

How long will I be in the hospital?

You can expect to stay in the hospital for about 2-4 weeks after receiving the CAR T-cells for close monitoring.

Will this treatment cure my cancer?

This is a Phase 1 study to check safety and how the treatment works. We don't know if it will cure cancer, but it helps doctors learn more about fighting this disease.