Treg Immunotherapy in Crohn's Disease

Summary

Crohn's Disease (CD) is a condition that causes inflammation of the digestive system or gut. Crohn's can affect any part of the gut, though the most common area affected is the end of the ileum (the last part of the small intestine), or the colon. Crohn's is a chronic condition. This means that it is ongoing and life-long, although patients may have periods of good health (remission), as well as times when symptoms are more active (relapses or flare-ups). Current available therapies frequently fail to maintain long-term remission and may be complicated by significant side effects. There is an unmet medical need for novel therapies. Cellular therapies are emerging as potentially attractive therapeutic strategies. The TRIBUTE trial will use autologous regulatory T cells (Tregs) expanded in vitro. It is hoped that the administration of this treatment to patients with active CD will change the immune responses in the gut and reduce bowel wall inflammation.

Timeline

Start

2022-08-08

Primary completion

2024-03-31

Completion

2025-06-30

Publications

• Background Canavan JB, Scotta C, Vossenkamper A, Goldberg R, Elder MJ, Shoval I, Marks E, Stolarczyk E, Lo JW, Powell N, Fazekasova H, Irving PM, Sanderson JD, Howard JK, Yagel S, Afzali B, MacDonald TT, Hernandez-Fuentes MP, Shpigel NY, Lombardi G, Lord GM. Developing in vitro expanded CD45RA+ regulatory T cells as an adoptive cell therapy for Crohn's disease. Gut. 2016 Apr;65(4):584-94. doi: 10.1136/gutjnl-2014-306919. Epub 2015 Feb 24.
• Rodger B, Clough J, Vasconcelos J, Canavan JB, Macallan D, Prevost AT, Lord GM, Irving P. Protocol for a first-in-human feasibility study of T regulatory cells (TR004) for inflammatory bowel disease using (ex vivo) Treg expansion (TRIBUTE). BMJ Open. 2025 Jan 23;15(1):e092733. doi: 10.1136/bmjopen-2024-092733.
• Goldberg R, Scotta C, Cooper D, Nissim-Eliraz E, Nir E, Tasker S, Irving PM, Sanderson J, Lavender P, Ibrahim F, Corcoran J, Prevost T, Shpigel NY, Marelli-Berg F, Lombardi G, Lord GM. Correction of Defective T-Regulatory Cells From Patients With Crohn's Disease by Ex Vivo Ligation of Retinoic Acid Receptor-alpha. Gastroenterology. 2019 May;156(6):1775-1787. doi: 10.1053/j.gastro.2019.01.025. Epub 2019 Jan 30.

Drugs

Indications