RecruitingRecruiting
A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
NCT05926765 · MeiraGTx UK II Ltd
In plain English
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Official title
A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
About this study
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.
Eligibility criteria
Inclusion Criteria:
* 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 Criteria:
* 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%)
Study design
Enrollment target: 276 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2023-06-13
Estimated completion: 2026-12
Last updated: 2026-02-02
Interventions
Genetic: AAV2-hAQP1 Concentration 1Genetic: AAV2-hAQP1 Concentration 2Other: PlaceboGenetic: AAV2-hAQP1 Concentration 3Genetic: AAV2-hAQP1 Concentration 4
Primary outcomes
- • Change from Baseline to Month 12 in Xerostomia-specific Questionnaire (XQ) Total Score (12 months)
Sponsor
MeiraGTx, LLC · industry
Contacts & investigators
ContactMeiraGTx Clinical Project Manager · contact · MGT-AQP1-201@meiragtx.com · 646-860-7982
All locations (33)
Banner MD Anderson Cancer CenterRecruiting
Gilbert, Arizona, United States
City of HopeRecruiting
Duarte, California, United States
Miami Cancer Institute at Baptist Health South FloridaRecruiting
Miami, Florida, United States
University of IowaRecruiting
Iowa City, Iowa, United States
Johns Hopkins HospitalRecruiting
Baltimore, Maryland, United States
Tufts University School of Dental MedicineRecruiting
Boston, Massachusetts, United States
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States
Henry Ford HealthRecruiting
Detroit, Michigan, United States
University of MissouriRecruiting
Columbia, Missouri, United States
Washington University - St. LouisRecruiting
St Louis, Missouri, United States
Erie County Medical CenterRecruiting
Buffalo, New York, United States
UNC-Chapel HillRecruiting
Chapel Hill, North Carolina, United States
Atrium HealthRecruiting
Charlotte, North Carolina, United States
Penn StateRecruiting
Hershey, Pennsylvania, United States
Alleghany General HospitalRecruiting
Pittsburgh, Pennsylvania, United States
Johnson City Medical CenterRecruiting
Johnson City, Tennessee, United States
UT Southwestern Medical CenterRecruiting
Dallas, Texas, United States
Houston MethodistRecruiting
Houston, Texas, United States
Shirley and Jim Fielding Northeast Cancer Centre - Health Sciences NorthRecruiting
Greater Sudbury, Ontario, Canada
Hopital Fleurimont, CIUSSS de l'Estrie-CHUSRecruiting
Québec, Canada
Princess Margaret Cancer CentreRecruiting
Toronto, Canada
CIUSSS-MCQ (Trois-Rivières, QC)Recruiting
Trois-Rivières, Canada
Addenbrooke's HospitalRecruiting
Cambridge, United Kingdom
Cardiff and Vale NHS Trust - Head & Neck ServicesRecruiting
Cardiff, United Kingdom
Ninewells Hospital & Medical SchoolRecruiting
Dundee, United Kingdom
Glasgow Royal InfirmaryRecruiting
Glasgow, United Kingdom
Leeds Dental InstituteRecruiting
Leeds, United Kingdom
Western GeneralRecruiting
London, United Kingdom
Guys HospitalRecruiting
London, United Kingdom
The Royal MarsdenRecruiting
London, United Kingdom
University College London Hospitals NHS Foundation TrustRecruiting
London, United Kingdom
Nottingham University Hospitals NHS TrustRecruiting
Nottingham, United Kingdom
York HospitalRecruiting
York, United Kingdom