Treg Immunotherapy in Crohn's Disease - TRIBUTE Feasibility Study
Research type
Research Study
Full title
A First In Human feasibility study of T regulatory cells (TR004) for Inflammatory Bowel Disease Using (ex vivo) Treg Expansion
IRAS ID
1003824
Contact name
Peter Irving
Contact email
Sponsor organisation
Guy's and St Thomas NHS Foundation Trust
Eudract number
2017-000170-11
ISRCTN Number
ISRCTN97547683
Research summary
Crohn’s disease (CD) is a chronic, immune-mediated inflammatory bowel disease with no known cure, causing symptoms such as bloody diarrhoea and abdominal pain. Goals of therapy include improvement of symptoms and healing of the bowel lining. Many patients have an incomplete or short-lived response to current treatments or develop side effects, and so there is a pressing need for new therapies.
CD develops from an overactive or misdirected immune response. Regulatory T-cells (Tregs) regulate or suppress other cells in the immune system. In CD, the immune system is resistant to the normal suppressive action of Tregs, leading to inflammation in the bowel wall.
TRIBUTE is looking at a new type of treatment called Treg immunotherapy. The patient’s white blood cells will be extracted from their blood and grown in a laboratory following a validated manufacturing process. It will take up to 23 days to make enough cells for the treatment.
The aims of the study are to explore the side effects of the therapy, to observe how the patient’s immune system reacts to the novel treatment, and to see how feasible it would be to test the treatment in a larger trial. It is hoped giving this treatment to patients with active CD will change the immune responses in the gut and reduce bowel wall inflammation.
The trial will recruit patients with active Crohn’s disease who did not tolerate or did not respond to at least 2 prior standard treatments. All patients will be recruited and treated at Guy’s and St Thomas NHS Foundation Trust. Participants will be recruited in pairs and each participant will be randomly allocated to receive either the Treg immunotherapy or placebo, before crossing over 8 weeks later and receiving the other treatment. Participants will be in the study for 24 months. They will undergo various tests, including blood tests, physical examinations, colonoscopies and biopsies to assess their eligibility and to monitor their safety throughout the study.
REC name
North East - York Research Ethics Committee
REC reference
22/NE/0062
Date of REC Opinion
16 May 2022
REC opinion
Further Information Favourable Opinion