Actively Recruiting
A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
Led by MeiraGTx, LLC · Updated on 2026-02-02
276
Participants Needed
33
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will assess the efficacy and safety of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.
CONDITIONS
Official Title
A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 (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 Xerostomia-specific Questionnaire (XQ) Total Score at or above a specified threshold
- No evidence of head and neck cancer by negative otolaryngology exam and CT scan of head, neck, and chest with contrast (or recent MRI, PET, or FDG-PET within 6 months)
- Either discontinued prescription sialagogue therapy or elected not to start it
- Participants using pilocarpine or cevimeline must stop at least 2 weeks before screening and agree to avoid during the study
- Stable dose for at least one month prior to screening of any medications known to affect salivary output for underlying medical conditions
You will not qualify if you...
- 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 salivary glands (e.g., Sjogren's disease)
- Use of systemic immunosuppressive medications within 4 weeks before screening (topical, inhaled, or intranasal corticosteroids allowed)
- Active Epstein-Barr virus infection (positive anti-VCA IgM)
- Active Hepatitis C virus infection
- Human immunodeficiency virus (HIV) infection
- Diagnosis of myasthenia gravis
- Personal or family history of acute or chronic angle-closure glaucoma or at increased risk for it
- Known allergy or sensitivity to glycopyrrolate
- Current smokers or those who smoked or vaped with tobacco additives within the past 3 years
- Current or recent (past 3 years) alcohol misuse as defined by local guidelines
- Poorly controlled diabetes with hemoglobin A1c >7%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
3
Miami Cancer Institute at Baptist Health South Florida
Miami, Florida, United States, 33176
Actively Recruiting
4
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
5
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
Actively Recruiting
6
Tufts University School of Dental Medicine
Boston, Massachusetts, United States, 02111
Actively Recruiting
7
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
Actively Recruiting
8
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
9
University of Missouri
Columbia, Missouri, United States, 65212
Actively Recruiting
10
Washington University - St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
11
Erie County Medical Center
Buffalo, New York, United States, 14215
Actively Recruiting
12
UNC-Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
13
Atrium Health
Charlotte, North Carolina, United States, 28203
Actively Recruiting
14
Penn State
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
15
Alleghany General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
16
Johnson City Medical Center
Johnson City, Tennessee, United States, 37604
Actively Recruiting
17
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
18
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
19
Shirley and Jim Fielding Northeast Cancer Centre - Health Sciences North
Greater Sudbury, Ontario, Canada, P3E 5J1
Actively Recruiting
20
Hopital Fleurimont, CIUSSS de l'Estrie-CHUS
Québec, Canada, J1H 5HE
Actively Recruiting
21
Princess Margaret Cancer Centre
Toronto, Canada, M5G 2C4
Actively Recruiting
22
CIUSSS-MCQ (Trois-Rivières, QC)
Trois-Rivières, Canada, G8Z 3R9
Actively Recruiting
23
Addenbrooke's Hospital
Cambridge, United Kingdom
Actively Recruiting
24
Cardiff and Vale NHS Trust - Head & Neck Services
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
25
Ninewells Hospital & Medical School
Dundee, United Kingdom, DD1 9SY
Actively Recruiting
26
Glasgow Royal Infirmary
Glasgow, United Kingdom, LS2 9LU
Actively Recruiting
27
Leeds Dental Institute
Leeds, United Kingdom, LS2 9LU
Actively Recruiting
28
Western General
London, United Kingdom, EH4 2XU
Actively Recruiting
29
Guys Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
30
The Royal Marsden
London, United Kingdom, SW3 6JJ
Actively Recruiting
31
University College London Hospitals NHS Foundation Trust
London, United Kingdom, WC1E 6DG
Actively Recruiting
32
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG7 2UH
Actively Recruiting
33
York Hospital
York, United Kingdom, YO31 8HE
Actively Recruiting
Research Team
M
MeiraGTx Clinical Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here