RecruitingPHASE1INTERVENTIONAL

CAR T Cells to Target GD2 for DMG

This study, called CARMIGO, is investigating a new treatment for children and young adults aged 2-16 who have a specific type of brain tumour called Diffuse Midline Glioma (DMG). The treatment uses special modified cells called GD2 CAR T cells. In this first phase of the study, researchers want to find out how safe the treatment is and if patients can generally tolerate it. They also want to understand how well these special cells grow and stay active in the body after they are given. The study is particularly looking at a type of DMG linked to a specific gene change (H3 K27M-Mutant). It's a key step in exploring new ways to fight this challenging condition.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

University College, London

Enrolment target

Start

15 Aug 2023

Estimated completion

01 Dec 2039

Diffuse Midline Glioma, H3 K27M-Mutant

What is this study about?

The CARMIGO study is a new clinical trial focusing on a serious type of brain tumour called Diffuse Midline Glioma (DMG), which affects children and young people. This specific type of DMG has a particular change in a gene (H3 K27M-Mutant). Doctors and scientists are looking for better ways to treat it, and this study explores a new approach using what are called 'CAR T cells'. Imagine your body's immune system as a police force; T cells are like special officers. In this treatment, these T cells are taken from the patient, taught to recognise and fight the cancer cells, and then put back into the body.

The main goal of this study is to learn about the safety of these modified T cells, called GD2 CAR T cells. It's the first stage of testing (Phase 1), which means researchers are especially careful to watch for any side effects and understand how the body reacts to the treatment. They also want to see if the body can successfully create these special cells and if these cells can grow and stay active for a period of time after they are given to the patient.

This study is important because DMG is a very challenging cancer to treat. By carefully studying this new type of cellular therapy, researchers hope to gather vital information that could potentially lead to more effective treatments in the future. It’s a step towards understanding whether this clever way of using the body's own immune system can make a difference for young patients.

Key takeaways

This study is testing a new, experimental immune cell therapy (CAR T cells) for children and young people with a type of brain tumour called DMG.
The main goal is to check how safe the treatment is and how the body reacts to it.
Patients' own cells are taken, specially modified, and then given back as treatment.
There will be monitoring in the hospital for several weeks after treatment.
This is an early-stage study, so potential risks and benefits are still being understood.
Participation is entirely voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, patients need to be between 2 and 16 years old and have a specific type of Diffuse Midline Glioma (DMG) that has a particular gene change (H3K27M mutant). Their tumour should only be in the brainstem or spinal cord. It's also important that they have finished any radiation treatment at least 6 weeks before starting this study and aren't currently taking high doses of certain steroid medications.

There are also some general health requirements. Patients need to have generally good blood counts (like enough white blood cells and platelets) and their kidneys and liver should be working well. They must also be able to undergo a procedure to collect their blood cells safely.

Some reasons why a patient might not be able to join include having certain other serious health conditions, active infections like hepatitis or HIV, or if their tumour is showing signs of getting worse through new growth or spread. Also, if they have certain allergies or can't have specific medical procedures required for the study, they might not be eligible.

Quick self-check

Are you between 2 and 16 years old?
Do you have Diffuse Midline Glioma (DMG) with an H3K27M gene change?
Has it been at least 6 weeks since your radiation treatment finished?
Are your general blood counts, kidney, and liver functions mostly normal?
Are you able to have a procedure to collect your blood cells?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the study, your journey will start with a procedure called 'leukapheresis'. This is where blood is taken from you, certain cells are separated, and the rest of the blood is returned. These collected cells are then sent to a special lab to be modified into the GD2 CAR T cells for your treatment, which takes about 15 days to prepare.

Before you receive the CAR T cells, a small tube called an Ommaya catheter might be gently placed under your skin into a space in your brain. This helps doctors monitor and manage any pressure changes in your head. You will also receive a short course of chemotherapy drugs (called fludarabine and cyclophosphamide) for a few days before the CAR T cells are given. This chemotherapy helps prepare your body to receive the new cells.

The GD2 CAR T cells will then be given to you through a drip. You'll be closely monitored in the hospital for about 2 to 4 weeks after receiving the treatment. Some patients, if their initial treatment doesn't fully work and if they don't have serious side effects, might have the option to receive a second type of CAR T cell treatment directly into the brain through the Ommaya catheter. The total duration of follow-up will be carefully explained by the study team.

Potential risks and benefits

Participating in a study like this means you might be among the first to receive a new and experimental treatment for Diffuse Midline Glioma. While this offers hope for a condition that is difficult to treat, it's important to remember that the main aim of this early stage study is to find out if the treatment is safe and how the body handles it. Because it's a new treatment, there might be side effects or risks that are not fully known yet, including problems like fevers, feeling unwell, or other reactions from your immune system. The medical team will carefully monitor you for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Great Ormond Street Hospital
London, United Kingdom· Recruiting

Common questions

What is Diffuse Midline Glioma (DMG)?

DMG is a serious type of brain tumour that grows in important areas of the brain or spinal cord, mostly affecting children and young people.

What are CAR T cells?

CAR T cells are a special type of your own immune white blood cells that have been specially trained in a lab to find and fight cancer cells.

Is this a cure for DMG?

This is an early-stage study (Phase 1) focused on checking the safety of a new treatment. It's not yet known if it's a cure, but it's a step towards finding better treatments.

Will I have chemotherapy?

Yes, you will receive some chemotherapy drugs for a few days before getting the CAR T cells, to help prepare your body for the new cells.

How long will I be in the hospital?

You'll be closely monitored in the hospital for around 2 to 4 weeks after receiving the CAR T cell treatment.

How to find out more

CARMIGO Trial Coordinator

ctc.CARMIGO@ucl.ac.uk 0207 679 9599 Official trial record

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