RecruitingPhase IInterventional

CAR T cells for T cell cancers

This study is looking into a new treatment for T-cell cancers (T-ALL or T-LBL) that are difficult to cure or have returned after previous treatments. These cancers are aggressive, and current options like chemotherapy and transplants can be tough or not work. The new treatment uses your body's own immune cells, called T-cells. We take a sample of your T-cells, fine-tune them in the lab to recognise and attack your cancer cells, and then give them back to you. These specially trained cells are called CAR T-cells. The main goal is to find out if this treatment is safe and to determine the most effective dose for both children and adults.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

University College London

Enrolment target

Start

31 Jul 2025

Estimated completion

30 Sep 2027

Relapsed or refractory T-cell malignancies (T-ALL or T-LBL)

What is this study about?

T-cell Acute Lymphoblastic Leukaemia (T-ALL) and T-cell Lymphoblastic Lymphoma (T-LBL) are serious types of cancer that are often difficult to treat effectively. Sometimes, these cancers don't respond well to standard treatments, or they come back after treatment has finished. For people in this situation, there aren't many other treatment options available, and those that exist, like strong chemotherapy followed by a stem cell transplant, can be very hard on the body and carry significant risks.

This study is exploring a new and different approach using something called CAR T-cells. T-cells are a type of immune cell in your blood that normally helps fight off infections. In this treatment, doctors take a sample of your T-cells and send them to a lab. There, they are specially changed to become super-fighters that can spot and destroy your cancer cells. These re-programmed cells are then given back to you.

We already know that CAR T-cell therapy has been successful in treating another type of leukaemia, giving many patients long-lasting relief from their cancer. This study is taking that idea and developing a new type of CAR T-cell that targets a specific marker, called CCR9, which is found on most T-cell cancer cells. The main aims are to test if these new CAR T-cells are safe for patients and to work out the best amount (dose) to give. The study plans to involve 12 children (under 18) and 12 adults.

Key takeaways

Tests a new CAR T-cell treatment for hard-to-treat T-cell cancers.
Uses your own immune cells, specially trained to fight cancer.
Aims to check safety and find the best dose.
Suitable for adults and children whose cancer has returned or resists treatment.
Involves a hospital stay and two years of follow-up check-ups.
Potential benefits, but also possible side effects that will be closely monitored.

Who may be eligible?

This study is for people who have T-ALL or T-LBL that has either come back or hasn't responded to previous treatments. For adults, you need to have had at least one standard treatment before. For children, you need to have had at least two standard treatments.

Your cancer must show a specific marker called CCR9. There are also some basic health requirements to make sure you can safely take part. For example, your heart, lungs, and kidneys need to be working well, and you shouldn't have certain other serious infections like active hepatitis or HIV.

There are also some things that would mean you can't join. For instance, if you are pregnant or breastfeeding, or if your general health isn't strong enough. The study team will check all these details carefully with you and your doctors.

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.

Do I have T-ALL or T-LBL that has returned or not responded to treatment?
For adults, have I had at least one previous standard cancer treatment?
For children, have I had at least two previous standard cancer treatments?
Does my cancer show the CCR9 marker?
Am I generally well enough to undergo the treatment?
Am I pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a procedure called leukapheresis, where some of your blood is taken to collect your T-cells. These cells are then sent away to be specially prepared. Before you receive the new CAR T-cells, you'll have a short course of chemotherapy, which helps prepare your body for the treatment.

The CAR T-cells will then be given to you through a drip, similar to a blood transfusion. You will need to stay in the hospital for at least two weeks so the doctors and nurses can watch you very closely for any side effects. After you leave the hospital, you'll have regular follow-up appointments for two years. These check-ups will involve blood tests, scans, and sometimes bone marrow tests to see how you are doing and how the treatment is working.

Potential risks and benefits

The main potential benefit of joining this study is that you could receive a new treatment for your T-cell cancer that might be more effective than other options, especially if your cancer hasn't responded to previous treatments. While there's no guarantee, past CAR T-cell studies for other cancers have shown promising results. However, there are also potential risks involved. The process of collecting your T-cells can cause some discomfort like bruising, and the chemotherapy given before the CAR T-cells can have side effects like temporary nausea or a lowered immune system. The CAR T-cells themselves can cause side effects like fever or feeling unwell, which doctors will monitor very closely, and in rare cases, more serious problems could occur. You are free 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.

Not provided at time of registration
Unverified
United Kingdom

Common questions

What is a 'CAR T-cell'?

CAR T-cells are your own immune cells that have been specially trained in a lab to find and kill your cancer cells more effectively.

What does 'relapsed or refractory' mean?

This means your cancer has either come back after treatment, or it hasn't responded well to previous treatments you've had.

How long will I be in hospital for the main treatment?

You'll need to stay in the hospital for at least two weeks after receiving the CAR T-cells so doctors can monitor you closely.

Who is funding this study?

The study is funded by the Medical Research Council (UK) and Great Ormond Street Hospital Children's Charity (UK).

How long will the study go on for?

The study plans to run from April 2025 to December 2035, and participants will have follow-up appointments for two years after treatment.

How to find out more

FRACTALL Trial Manager

ctc.fractall@ucl.ac.uk - Official trial record

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