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INTERCEPT-Lynch: A Phase 1/2 Open-label, Dose-escalation, and Dose-expansion Study of mRNA-4194 in Participants with Lynch Syndrome

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.

INTERCEPT-Lynch is not yet recruiting participants, we anticipate the trial will open in spring/summer 2026.