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A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT05926765•MeiraGTx, LLC

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)
+2 more criteria

Locations (33)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

City of Hope

Duarte, California, United States

Miami Cancer Institute at Baptist Health South Florida

Miami, Florida, United States

University of Iowa

Iowa City, Iowa, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Henry Ford Health

Detroit, Michigan, United States

University of Missouri

Columbia, Missouri, United States

Washington University - St. Louis

St Louis, Missouri, United States

Key Dates

Start Date

June 13, 2023

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

February 2, 2026

Enrollment

276

ESTIMATED participants

Conditions

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

Interventions

AAV2-hAQP1 Concentration 1

GENETIC

AAV2-hAQP1 Concentration 2

GENETIC

Placebo

OTHER

AAV2-hAQP1 Concentration 3

GENETIC

AAV2-hAQP1 Concentration 4

GENETIC

Contacts

MeiraGTx Clinical Project Manager

CONTACT

646-860-7982 MGT-AQP1-201@meiragtx.com