Study of AAV2-hAQP1 Gene Therapy for Radiation-Induced Dry Mouth
This study is looking at a gene therapy called AAV2-hAQP1 for people who have severe dry mouth (xerostomia) caused by radiation treatment for head and neck cancer. You might be able to join if you completed radiation therapy at least three years ago and have Grade 2 or 3 dry mouth. The study will give different amounts of AAV2-hAQP1 or a placebo (an inactive substance) into your parotid glands (salivary glands in your cheeks). Researchers want to see if AAV2-hAQP1 is safe and helps improve your dry mouth symptoms, measured by a special questionnaire after 12 months. The current status of this study is unclear, and it plans to enroll about 290 participants.
- Study design
- This is an interventional study comparing different concentrations of AAV2-hAQP1 gene therapy to a placebo. It plans to enroll about 290 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your dry mouth symptoms will be assessed for 12 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05926765
A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatmentMeiraGTx, LLC
~290 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:AAV2-hAQP1 Concentration 1AAV2-hAQP1 Concentration 2PlaceboAAV2-hAQP1 Concentration 3AAV2-hAQP1 Concentration 4
At a glance
Recruiting sites
0 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline to Month 12 in Xerostomia-specific Questionnaire (XQ) Total Score
Measured over 12 months
Conditions
Where it's being run
33 sites across 16 statesUnited Kingdom11
Canada3
Massachusetts2
Missouri2
North Carolina2
Pennsylvania2
Texas2
Arizona1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Completed beam radiation therapy for head and neck cancer at least 3 years prior to the first screening visit
No history of recurrent head and neck cancer, parotid gland cancer, or a second primary cancer, except for treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma
An unstimulated whole saliva flow rate (mL/min) \>0 (i.e., at least one drop of saliva in the collection tube)
A stimulated whole saliva flow rate (mL/min) within a specified range after mechanical stimulation by chewing
Average screening XQ Total Score at or above a specified threshold
No evidence of head and neck cancer, defined as a negative otolaryngology exam and a negative computed tomography (CT) scan of the head, neck, and chest with contrast. If a participant has had a magnetic resonance imaging (MRI) study, CT scan, positron emission tomography (PET), or fluorodeoxyglucose-positron emission tomography (FDG-PET) scan of the head, neck, and chest within 6 months of signing the informed consent form (and at least 3 years after the completion of radiotherapy), then that scan may be used for eligibility determination and a CT scan at screening will not be required. If the CT of the neck captures images from the forehead down to the neck, no CT of the head is required.
Either received treatment with one or more prescription sialagogues and elected to discontinue therapy or, in consultation with their physician, elected not to initiate such treatment
Participants taking a prescription sialagogue (specifically, pilocarpine or cevimeline) must stop that medication at least 2 weeks prior to Screening and be willing to refrain from taking such medications for the duration of the study
Participants who require medication for an underlying medical condition that is known to affect salivary output must be on stable doses of such medications for at least one month prior to the first screening visit
Exclusion
History of recurrent head and neck cancer, parotid gland cancer, or a second primary cancer, except for treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma
History of systemic autoimmune disease affecting the salivary glands (e.g., Sjogren's disease)
Currently using systemic immunosuppressive medication(s) (e.g., corticosteroids or biologics) or treated with one within 4 weeks of the first screening visit. Note: Topical, inhaled, or intranasal corticosteroids are permitted.
Active viral infection with Epstein-Barr virus (EBV), defined as a positive anti-VCA IgM. In the event a potential participant has a positive anti-VCA IgM, they may be rescreened 2-4 months later at which time a positive Epstein-Barr Virus Nuclear Antigen (EBNA) will be considered as evidence of resolved EBV infection.
Evidence of active Hepatitis C virus (HCV) infection
Evidence of human immunodeficiency virus (HIV) infection
Diagnosis of myasthenia gravis
Personal or family history of acute or chronic angle-closure glaucoma (ACG), or at increased risk of developing ACG, or had prophylactic treatment to reduce the risk of developing ACG
Known allergy or hypersensitivity to glycopyrrolate
Current smokers or history of smoking within the preceding 3 years (includes vaping with tobacco additives)
Current alcohol misuse or a history of the same within the preceding 3 years, as defined by local guidance. In North America, an average intake for men of more than 14 drinks per week, and for women more than 7 drinks per week, consistent with the US National Institute of Alcohol Abuse and Alcoholism. In the UK, an average intake of more than 14 units per week for both men and women, consistent with the UK Chief Medical Officers' Low Risk Drinking Guidelines.
Poorly controlled diabetes (hemoglobin A1c \>7%)
What this trial measures
- Change from Baseline to Month 12 in Xerostomia-specific Questionnaire (XQ) Total Score12 months
The XQ consists of 8 symptom-specific questions the participant rates from 0 (not present) to 10 (worst possible). The XQ Total Score is the sum of all individual item ratings and ranges from 0 to 80.