Gene therapy to restore saliva production after head and neck cancer radiation

Plain-English translation of NCT05926765 on ClinicalTrials.gov ↗ · Source last updated February 2026 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing AAV2-hAQP1, a gene therapy that works by delivering a healthy gene directly into your parotid glands (the large salivary glands in your cheeks). The treatment is injected through a natural opening in your mouth, and the goal is to help your damaged glands produce saliva again. This medication has never been tested in humans before, so this study will carefully measure whether it is safe and whether it actually works to reduce dry mouth.

Many people who received radiation therapy for head and neck cancer develop severe, lasting dry mouth because the radiation damages their salivary glands. Current treatments like oral medications can help a little, but they don't address the root problem. This trial exists to test whether delivering a healthy gene directly into the glands could restore their natural ability to make saliva.

Do you qualify?

You likely qualify if…

you completed radiation therapy for head and neck cancer at least 3 years ago
you have moderate to severe dry mouth (Grade 2 or 3) as a result of that radiation
you still produce at least a tiny amount of saliva when tested
you have not had cancer return or develop a new cancer since your radiation treatment
you have tried or decided not to use prescription dry-mouth medications and are willing to stop taking them during the study

You likely don't qualify if…

you have a history of Sjögren's disease or other autoimmune disease affecting your salivary glands
you are currently taking immune-suppressing medications (such as steroids or biologics) or took them within 4 weeks of screening
you have an active infection with Epstein-Barr virus, hepatitis C, or HIV
you have a diagnosis of myasthenia gravis
you have a history of cancer returning or a second primary cancer (other than treated skin cancer)

What participation looks like

If you qualify and are assigned to receive treatment, you will have an injection of the medication or placebo delivered through a small opening in your mouth directly into each of your parotid glands (a procedure that takes less than an hour). You will be randomly assigned to receive one of several different doses of the medication or a placebo so that researchers can learn which dose works best and is safest. You'll then return for follow-up visits over time so the study team can measure whether your dry mouth improves and watch for any side effects.

AI-generated summary from trial data · Jun 6, 2026 · Not medical advice

Trial locations(33 sites)

United States

Banner MD Anderson Cancer Center, Gilbert, Arizona

City of Hope, Duarte, California

Miami Cancer Institute at Baptist Health South Florida, Miami, Florida

University of Iowa, Iowa City, Iowa

Johns Hopkins Hospital, Baltimore, Maryland