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Can a single gene therapy dose restore saliva flow years after radiation?

NCT ID NCT05060341

Symptom relief Sponsor: MeiraGTx, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This study follows people who received an experimental gene therapy, AAV2hAQP1, for chronic dry mouth caused by past radiation treatment for cancer. Researchers are checking whether the therapy remains safe and whether any improvement in saliva production lasts over time. The goal is to understand the long-term effects of this one-time treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a gene therapy called AAV2hAQP1, designed to help salivary glands produce more saliva
What this could lead to
If successful, this could point toward a durable treatment for chronic dry mouth caused by radiation therapy.
What could go wrong
This is a small, early-stage follow-up study focused on safety, not proof of effectiveness. The therapy may not improve symptoms for everyone.
Why investors are watching

MeiraGTx Holdings plc is running a long-term follow-up study for patients who received its gene therapy AAV2hAQP1 in an earlier phase 1 trial for dry mouth caused by radiation treatment for head and neck cancer. The therapy aims to ease symptoms by helping the salivary glands produce more saliva. For a micro-cap company, this readout matters because it shows whether the treatment's effects last over time, which is key to its value.

If it works: If the follow-up data show that patients continue to have improved saliva production and symptom relief without new safety problems, MeiraGTx could use those results to support further development and regulatory discussions. That could strengthen the company's position as it moves the therapy toward later-stage trials.

If it fails: The follow-up could reveal that the treatment's benefits fade or that late side effects appear, which would hurt the therapy's prospects. Trials often fail to meet expectations, and a negative or delayed readout could set back MeiraGTx's plans for this product.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

22 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects with radiation induced parotid gland hypofunction and xerostomia who have particpated in the MGT016 AAV2hAQP1 study.

Ages

18 to 81 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Are willing and able to provide informed consent 2. Received AAV2hAQP1 administered via Stensen's duct to a single or both parotid glands in the prior open-label, Phase 1, dose-escalation study (Study MGT016) 3. Are willing and able to adhere to the protocol and long-term follow-up Exclusion Criteria: 1\. Subjects unwilling or unable to meet with the requirements of the study will be excluded

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Radiation induced xerostomia

Contacts and locations

Locations

  • Atrium Health

    Charlotte, North Carolina, 28209, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02184, United States

  • Health Sciences North - Northeast Cancer Center

    Greater Sudbury, Ontario, Canada

  • Leland Stanford Junior University

    Stanford, California, 94305, United States

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