KAN101

Coeliac disease is digestive and autoimmune disorder that affects your small intestine. Coeliac disease can be triggered by a protein called gluten that is found in grains, like wheat, barley and rye. People with coeliac disease like you may experience symptoms like diarrhoea, bloating, abdominal pain, and other symptoms involved in multiple organs beyond the small intestine. Currently there is no drug that is available to treat coeliac disease. The only available option is following a strict gluten-free diet. This can be difficult for some patients with coeliac disease because of the uncertainty about which foods and medications contain gluten, and the cost of gluten free products.

The study drug (KAN-101) acts by reprogramming immune cells to become tolerant, or not react, specifically toward gluten. The drug is designed to not suppress the other parts of your immune system and only impact the cells that respond to gluten. This study will explore whether the study drug is effective in blocking the immune response to gluten and if it is safe for human-use.

Participants are in the study for up to 56 weeks which consists of 3 phases:

1. Screening (4 weeks, includes upper gastrointestinal endoscopy and biopsy)
2. Treatment (1 week, includes 3 single day infusions)
3. Follow-up (51 weeks, includes 4 single day gluten challenges)

Participants will be required to visit the research site 10 times.

Trial registration information https://clinicaltrials.gov/study/NCT05574010.