CompletedPhase I/IIInterventional

Treg Immunotherapy in Crohn’s Disease

Crohn’s disease is a lifelong condition causing painful swelling and irritation in the digestive system. When usual treatments stop working, managing symptoms can be very difficult. The TRIBUTE trial is testing a new, personalised treatment called regulatory T-cell (Treg) immunotherapy at Guy's Hospital in London. Tregs are natural immune cells that help stop inflammation. In this trial, doctors collect some of these cells from your blood. Scientists grow more of them in a specialised laboratory over several weeks. You then receive your own strengthened cells back through a vein via a drip. The main aim of this early-stage study is to check whether this therapy is safe and well tolerated. It also looks at whether the cells help calm gut inflammation. The trial is open to adults aged 18 to 80 whose Crohn's has not improved with at least two standard treatments.

At a glance

Status

Completed

Phase

Phase I/II

Enrolment target

Start

08 Aug 2022

Estimated completion

30 Nov 2023

Crohn's Disease

What is this study about?

Crohn’s disease is a long-term condition that causes inflammation in parts of the gut, leading to tummy pain, diarrhoea, fatigue, and weight loss. In a healthy body, the immune system defends against infections. In Crohn’s disease, however, the immune system mistakenly attacks healthy gut tissue. While existing medicines can help control symptoms, many people find that treatments stop working over time or cause unwanted side effects.

The TRIBUTE study is exploring a new way to help reset the immune system using a patient's own cells. Our bodies naturally produce special white blood cells called 'regulatory T-cells', or Tregs. These act like biological brakes, calming down inflammation and stopping the immune system from attacking healthy parts of the body. In this study, doctors take Tregs from a person's blood, multiply them in a clean laboratory, and give them back through a drip.

Because the treatment uses a person’s own cells, it is tailored specifically to them. This trial is an important early step to see if this method is safe to use in humans and whether it can soothe the inflamed bowel lining. If successful, it could pave the way for a brand-new type of therapy for people living with severe Crohn's disease who have run out of standard options.

Key takeaways

The TRIBUTE trial is testing a new personalised cell therapy to calm gut inflammation in Crohn's disease.
The treatment is made by growing your own calming immune cells (Tregs) in a laboratory.
It is aimed at adults whose condition has not responded to at least two standard treatments.
Participation involves screening tests, a cell collection visit, an overnight hospital stay for the infusion, and follow-up checks.
Taking part is voluntary, and you can withdraw at any time without losing any standard care.

Who may be eligible?

This study is designed for adults aged between 18 and 80 who have moderate to severe active Crohn’s disease. To qualify, you must have been diagnosed at least 12 weeks ago and currently have signs of active gut inflammation or ulcers shown on a camera test (colonoscopy).

Importantly, this trial is for people whose Crohn’s disease has not improved after trying at least two standard advanced medications, or who could not tolerate them. These include drugs like azathioprine, methotrexate, or biologic therapies like infliximab, adalimumab, or ustekinumab.

You must also be in generally good health otherwise. People with certain active infections—such as serious stomach bugs, viral hepatitis, or HIV—will not be able to join. The trial team will run heart checks and routine blood and stool tests during screening to make sure it is safe for you 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.

I am an adult aged between 18 and 80.
I have been diagnosed with Crohn's disease for at least 12 weeks.
My Crohn's symptoms are currently active and moderate to severe.
I have tried at least two standard or biologic medications that did not work or caused bad side effects.
I am willing to travel to London for hospital visits, tests, and an overnight stay.

Answer every question to see your result.

What does participation involve?

Taking part begins with a detailed screening stage lasting a few weeks to check your general health. This includes blood and stool tests, heart checks, scans, and a colonoscopy to view the lining of your bowel. If you are eligible, you will undergo a procedure called leukapheresis. During this visit, blood is gently drawn from one arm, passed through a machine that collects a portion of your white blood cells, and the rest of your blood is returned to your other arm.

Your collected cells are then sent to a clean laboratory to be grown and multiplied, which takes about 8 to 12 weeks. Once the treatment is ready, you will return to the hospital to receive your cells through a drip into your vein. You will stay overnight in hospital so doctors can closely monitor your recovery and watch for any immediate reactions.

After leaving the hospital, you will have regular clinic visits over several months. During these check-ups, the team will test your blood, check your vital signs, ask you to complete symptom diaries, and perform one further colonoscopy to see how your bowel lining is healing.

Potential risks and benefits

There is no guarantee that taking part will improve your Crohn's disease, but it is hoped that the therapy will help calm gut swelling. The information gathered may also help doctors develop better treatments for others in the future. Because the treatment uses your own cells, the risks are lower than receiving blood from someone else, but side effects can still happen. Common reactions include headaches, dizziness, mild skin rashes, or temporary swelling in your hands or ankles. Less commonly, you might develop a mild fever or chills. You may also get mild bruising from blood tests and drips. Remember, taking part is completely voluntary, and you are free to leave the study at any time without your regular NHS care being affected.

Locations (1)

Guy’s Hospital
Approximate
London, England

Common questions

Will I receive someone else's cells?

No. This therapy uses only your own white blood cells, which are collected, multiplied in a specialist laboratory, and returned to you.

Do I have to pay to take part?

No. The trial is funded by the Medical Research Council and run through the NHS, so all trial-related tests and treatments are free.

Where does the study take place?

The trial is based in London at Guy's Hospital and St Thomas' Hospital.

Will I have to stay overnight in hospital?

Yes. You will need to stay overnight for at least one night after receiving your cell infusion so the medical team can monitor your safety.

Can I leave the study if I change my mind?

Yes. You can withdraw from the study at any point without giving a reason, and your standard medical care will continue as normal.

How to find out more

Peter Irving

peter.irving@kcl.ac.uk +44 20 7188 2499 Official trial record

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