RecruitingPHASE1INTERVENTIONAL

A New Study Evaluating the Activity of Modular CAR T for mYeloma

This research trial is for people with multiple myeloma, a type of blood cancer, whose disease has returned or hasn't responded to previous treatments. It's an early-stage study (Phase 1) focused on checking the safety of a new kind of cell therapy called CAR T. CAR T-cell therapy uses your own white blood cells, which are specially changed in a lab to find and destroy cancer cells. The study is looking at two versions: one that targets a protein called BCMA on cancer cells, and another that targets both BCMA and CD19. Researchers will also test different doses to find the safest and most effective amount. The main goal is to understand if these new treatments are safe for patients.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

University College, London

Enrolment target

Start

22 Apr 2022

Estimated completion

31 Mar 2029

Multiple Myeloma

What is this study about?

This study is looking into a new way to treat multiple myeloma, a type of cancer that affects a specific kind of white blood cell in your bone marrow. This trial is designed for people whose multiple myeloma has come back after treatment or hasn't responded well to other therapies. Researchers are hopeful that this new approach, called CAR T-cell therapy, could offer another option for these patients.

CAR T-cell therapy is a very advanced treatment. It involves taking some of your own white blood cells, called T-cells, and sending them to a lab. There, they are specially modified to find and attack cancer cells. In this study, we're looking at two types of these modified T-cells. One type targets a specific marker on myeloma cells called BCMA. The other type targets both BCMA and another marker called CD19. The aim is to see how safe these therapies are and how the body reacts to them.

Because this is an early-stage study (Phase 1), the main focus is on safety. We will start with a small group of patients and give them a low dose of the CAR T-cells. If that dose is safe, we will gradually increase the dose for other patients. By carefully watching how people respond, we hope to find the right dose that is both safe and has the potential to help fight the cancer. The study will also check if it's possible to prepare these special cell treatments successfully for patients.

Key takeaways

This is a new, early-stage (Phase 1) study for multiple myeloma that has come back or is resistant to treatment.
It uses a new type of cell therapy called CAR T-cell therapy.
The main aim is to check the safety of these new CAR T-cells and find the right dose.
Two types of CAR T-cells are being tested: one targeting BCMA, and another targeting both BCMA and CD19.
Participants will have their own cells collected, specially treated, and then given back as medicine.

Who may be eligible?

To join this study, you need to be at least 18 years old and have multiple myeloma that has come back or hasn't responded to at least three different types of treatment, including specific common medications. Your doctors must also agree that standard stem cell transplants are not suitable for you.

There are also some important health checks. Your general health and organ function, like your kidneys and heart, need to be good enough to take part. This will be checked by the study doctors. You also can't have certain other serious health problems, such as specific heart conditions, severe lung issues, or other past treatments like gene or cell therapy.

Before you can join, the study team will go through all the details with you. They will check all your medical information to make sure this study is the right fit for you and that you meet all the necessary requirements safely.

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 at least 18 years old?
Do you have multiple myeloma that has already been treated with at least three different therapies?
Has your multiple myeloma come back or not responded to your previous treatment?
Are your heart, kidney, and other main organs generally healthy?
Have you not had other gene or cell therapies before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the process will involve several steps. Firstly, some of your white blood cells will be collected. These cells will then be sent away to be specially prepared into CAR T-cells for your treatment. This preparation can take some time.

Before you receive the CAR T-cells, you will have some chemotherapy to prepare your body. Then, you will receive the CAR T-cells through a drip, similar to a blood transfusion. During and after this, you'll stay in the hospital so the medical team can closely monitor you for any side effects or how your body is responding to the treatment. This close monitoring is very important, especially in the early days and weeks after the infusion.

The study will involve regular follow-up visits after you leave the hospital. These visits will include check-ups, blood tests, and scans to see how you are doing and how well the treatment is working. The exact number and timing of these visits will be explained to you by the study team. The total duration of your active participation in the study, including follow-up, can be lengthy, possibly for several months or longer, to track the long-term effects of the therapy.

Potential risks and benefits

Taking part in this study might offer a potential benefit if your multiple myeloma has not responded to other treatments, by giving you access to a new experimental therapy that could help fight your cancer. However, as with all new treatments, there are potential risks and side effects that your doctors will discuss with you in detail. These can include issues like infection, fever, and other reactions to the cell therapy, which can sometimes be serious. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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· Recruiting

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects specific white blood cells (plasma cells) found in your bone marrow.

What are 'CAR T-cells'?

CAR T-cells are your own immune cells that have been specially changed in a lab to better find and destroy cancer cells.

Why is this called a 'Phase 1' study?

Phase 1 means it's an early safety study. The main goal is to see if the new treatment is safe for people and to work out the best dose.

Will I get one type of CAR T-cell or two?

The study offers two types of CAR T-cells. You might get one that targets BCMA, or one that targets both BCMA and CD19, depending on the study design.

Can I stop being part of the study once I start?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your normal medical care.

How to find out more

MCARTY Trial Coordinator

ctc.MCARTY@ucl.ac.uk 02076799599 Official trial record

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