Active not recruitingPHASE1INTERVENTIONAL

Multi-modular Chimeric Antigen Receptor Targeting GD2 in Neuroblastoma

The MAGNETO study is an early-stage clinical trial for children and teenagers aged 1-16 who have neuroblastoma that has returned or hasn't responded well to other treatments. This study aims to test a new immune cell therapy called GD2 CAR T cells. Scientists modify a patient's own immune cells (T cells) in the lab to help them find and fight neuroblastoma cells more effectively. The main goals are to see if these special cells can be successfully made for each patient and if the treatment is safe to give. Participants will receive chemotherapy before getting the new cell therapy, and then be carefully monitored for a long time to understand its effects.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

University College, London

Enrolment target

Start

19 Apr 2024

Estimated completion

01 Dec 2041

Neuroblastoma

What is this study about?

The MAGNETO study is looking into a new way to treat neuroblastoma, a type of cancer that usually starts in nerve cells outside the brain. This study is specifically for children and teenagers between 1 and 16 years old whose neuroblastoma has come back after treatment or hasn't responded to previous treatments.

The new treatment being tested uses something called GD2 CAR T cells. Imagine your body's immune system as a team of defenders. T cells are like the frontline soldiers. In this study, doctors take some of your own T cells and send them to a lab. There, scientists teach these T cells to recognise and attack neuroblastoma cells more effectively. They do this by adding a special 'GPS' (called GD2 CAR) that helps the T cells find a specific marker (GD2) on the cancer cells. They also add other features to help these special T cells stay active and fight the cancer for longer.

This is an early-stage study (called Phase I), which means the main goals are to find out if these special T cells can be successfully made for each patient, if the treatment is safe to give, and what the right dose might be. It's a bit like testing a new recipe – you want to make sure the ingredients work together and it's safe to eat. The study will also watch how well these specially trained T cells grow and survive in the body after they are given to the patient.

Key takeaways

This study evaluates a new cell therapy (GD2 CAR T cells) for neuroblastoma.
It's for children and teenagers (1-16 years old) whose cancer has come back or hasn't responded to previous treatments.
The main goals are to check the safety of the treatment and if the special cells can be made successfully.
Participants will receive chemotherapy before the cell therapy and have long-term follow-up.
This is an early-stage trial, so information on its effectiveness is still being gathered.

Who may be eligible?

To join the MAGNETO study, participants must be between 1 and 16 years old and have been diagnosed with neuroblastoma. This means your neuroblastoma must either have come back after other treatments or not have responded well to them.

You also need to have cancer that doctors can measure or see on scans, and your general health, including blood tests and organ function, should be good enough to take part in the study. Your doctors will check if you meet all the specific health requirements.

There are also reasons why someone might not be able to join. For example, if you only have cancer cells in your bone marrow without any other measurable tumours, or if you have certain other serious health conditions or infections, you might not be eligible. Also, if you can't have the process to collect your immune cells, you won't be able to take part.

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 between 1 and 16 years old?
Do you have a diagnosis of neuroblastoma that has come back or not responded to other treatments?
Can doctors see and measure your cancer on scans or tests?
Is your general health, including blood and organ function, considered stable enough for treatment?
Are you able to have a procedure to collect your immune cells (leukapheresis)?

Answer every question to see your result.

What does participation involve?

If you are eligible and decide to take part, the first step is to have a simple procedure called 'leukapheresis'. This is like donating blood, but a machine separates out your immune T cells, and the rest of your blood is returned to you. This usually takes a few hours. These cells are then sent to a lab to be specially trained, which takes about 15 days.

Before you receive the new GD2 CAR T cells, you'll have a short course of chemotherapy over approximately 4 days. This prepares your body to receive the new cells. After this, you will receive the specially trained CAR T cells through a drip. You'll stay in the hospital for about 2-4 weeks after the infusion so doctors can closely monitor you. After you go home, you will have regular check-ups for a full year. These check-ups will be at 6 weeks, and then every 3 months. Even after a year, you will continue to have yearly follow-up visits for up to 15 years to see how you are doing in the long term. If your cancer comes back within the first year, you'll move to annual follow-up sooner.

Potential risks and benefits

Participating in any clinical trial involves both possible benefits and risks. The potential benefit of this study is access to a new, experimental treatment for neuroblastoma that hasn't responded to other therapies. However, because this is an early-stage study, we don't know for sure how effective it will be. There are potential risks associated with the procedures, including the chemotherapy and the CAR T cell infusion itself, which can cause side effects. Your care team will explain all known side effects and monitor you closely for any issues. It's important to remember that joining is completely voluntary, and you have the right to withdraw from the study at any time without affecting your future medical care.

Locations (1)

Great Ormond Street Hospital
Verified postcode
London, United Kingdom

Common questions

What is neuroblastoma?

Neuroblastoma is a type of cancer that develops from immature nerve cells found in several areas of the body. It most commonly arises in and around the adrenal glands, but can also be found in the chest, neck, pelvis, or spinal cord.

What does 'relapsed or refractory' mean?

It means the cancer has either returned after being treated previously ('relapsed') or has not responded well to treatments you've already had ('refractory').

What are CAR T cells?

CAR T cells are a type of immune cell therapy. Your own immune cells (T cells) are collected, specially trained in a lab to find and fight cancer cells, and then put back into your body.

Will this treatment cure my neuroblastoma?

This is an early-stage study (Phase I), focused on finding out if the treatment is safe and can be successfully made. While the hope is that it could help, it's too early to say if it will cure neuroblastoma.

How long will I be followed up after treatment?

After the treatment, you'll be monitored closely for about a year with regular visits, and then you'll have annual check-ups for up to 15 years.