INTERCEPT Lynch
Research type
Research Study
Full title
A Phase 1/2 Open-label, Dose-escalation, and Dose-expansion Study of mRNA-4194 in Participants with Lynch Syndrome
IRAS ID
1012429
Contact name
David Church
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN78380445
Research summary
INTERCEPT-Lynch is a trial testing a treatment called mRNA-4194 for people with Lynch syndrome (LS). People with LS have a change in one of their genes meaning their bodies find it harder to stop cells becoming abnormal. This increases the risk of many types of cancer, most commonly in the bowel and in women, the womb. Bowel cancer in LS is often preceded by a small growth of abnormal cells called a polyp, which can be identified/removed by colonoscopy.
The mRNA-4194 treatment aims to help the immune system recognise and remove these early abnormal cells before they cause cancer. It works by giving the body short-term instructions to make harmless pieces of protein found in these abnormal cells. This may help the immune system train itself to spot and destroy similar cells in future.
The trial has two parts: In Part 1, up to 30 adults will receive 3 injections of mRNA-4194 into a muscle over 12 weeks to help find a dose that is well tolerated and activates the immune system. Part 2 includes another 80-110 adults, who will receive 4 injections over 6 months and 1 booster injection after a year. Participants will also have blood tests and colonoscopies to check for changes in bowel lining or polyps.
All participants will have regular visits for health checks, blood tests, and monitoring. Blood and tissue samples will be analysed in labs to see if mRNA-4194 can successfully train the immune system.
This trial will be the first time people are given mRNA-4194, so the side effects are unknown. Based on similar medications, the most common side effects are expected to be flu-like symptoms (tiredness, mild fever, chills, headache, muscle/joint aches) and symptoms where the injection is given (soreness, swelling, redness). Less commonly, these side effects may include more severe reactions at the injection site, and allergic reactions. The trial will help doctors assess the safety of mRNA-4194 and if it could help the immune system prevent cancer in people with LS.REC name
North East - York Research Ethics Committee
REC reference
26/NE/0046
Date of REC Opinion
5 May 2026
REC opinion
Further Information Favourable Opinion