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Clinical Trials in the UK / NCT05926765
Active, not recruiting Phase 2

A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia

NCT05926765 · tracked via the Priya Life Science UK tracker
Sponsor
MeiraGTx, LLC
Phase
Phase 2
Started
2023-06-13
Last updated
2026-07-24

Condition(s) studied

Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands

Investigational drug(s) / intervention(s)

AAV2-hAQP1 Concentration 1AAV2-hAQP1 Concentration 2PlaceboAAV2-hAQP1 Concentration 3AAV2-hAQP1 Concentration 4

AAV2-hAQP1 Concentration 1: Administration of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland

AAV2-hAQP1 Concentration 2: Administration of concentration 2 of AAV2-hAQP1 via Stensen's duct to each parotid gland

Placebo: Administration of diluent via Stensen's duct to each parotid gland

AAV2-hAQP1 Concentration 3: Administration of concentration 3 of AAV2-hAQP1 via Stensen's duct to each parotid gland

AAV2-hAQP1 Concentration 4: Administration of concentration 4 of AAV2-hAQP1 via Stensen's duct to each parotid gland

Study summary

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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%)

Primary outcome measure(s)

Trial sites (33)

FacilityCityRegionStatus
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
Tufts University School of Dental Medicine Boston Massachusetts
Brigham and Women's Hospital Boston Massachusetts
Henry Ford Health Detroit Michigan
University of Missouri Columbia Missouri
Washington University - St. Louis St Louis Missouri
Erie County Medical Center Buffalo New York
UNC-Chapel Hill Chapel Hill North Carolina
Atrium Health Charlotte North Carolina
Penn State Hershey Pennsylvania
Alleghany General Hospital Pittsburgh Pennsylvania
Johnson City Medical Center Johnson City Tennessee
UT Southwestern Medical Center Dallas Texas
Houston Methodist Houston Texas
Shirley and Jim Fielding Northeast Cancer Centre - Health Sciences North Greater Sudbury Ontario
Hopital Fleurimont, CIUSSS de l'Estrie-CHUS Québec Canada
Princess Margaret Cancer Centre Toronto Canada
CIUSSS-MCQ (Trois-Rivières, QC) Trois-Rivières Canada
Addenbrooke's Hospital Cambridge United Kingdom
Cardiff and Vale NHS Trust - Head & Neck Services Cardiff United Kingdom
Ninewells Hospital & Medical School Dundee United Kingdom
Glasgow Royal Infirmary Glasgow United Kingdom
Leeds Dental Institute Leeds United Kingdom
Western General London United Kingdom
Guys Hospital London United Kingdom
The Royal Marsden London United Kingdom
University College London Hospitals NHS Foundation Trust London United Kingdom
Nottingham University Hospitals NHS Trust Nottingham United Kingdom
York Hospital York United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05926765 on ClinicalTrials.gov ↗ ← All trials in the UK