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Phase 2

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

Sponsor:

MeiraGTx, LLC

Code:

NCT05926765

Conditions

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AAV2-hAQP1 Concentration 1

AAV2-hAQP1 Concentration 2

Placebo

AAV2-hAQP1 Concentration 3

AAV2-hAQP1 Concentration 4

Study Details

Brief 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.

Conditions

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

Study ID

NCT05926765

Start date

Jun 13, 2023

Status verified date

Jul, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

290 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1: AAV2-hAQP1 Group 1

Eligible participants will receive up to 3 mL of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland

experimental: Cohort 1: AAV2-hAQP1 Group 2

Eligible participants will receive up to 3 mL of concentration 2 of AAV2-hAQP1 via Stensen's duct to each parotid gland

placebo comparator: Cohort 1: Placebo group

Eligible participants will receive up to 3 mL of diluent via Stensen's duct to each parotid gland

experimental: Cohort 2: AAV2-hAQP1 Group 3

Eligible participants will receive up to 3 mL of concentration 3 of AAV2-hAQP1 via Stensen's duct to each parotid gland

experimental: Cohort 2: AAV2-hAQP1 Group 4

Eligible participants will receive up to 3 mL of concentration 4 of AAV2-hAQP1 via Stensen's duct to each parotid gland

placebo comparator: Cohort 2 Placebo group

Eligible participants will receive up to 3 mL of diluent via Stensen's duct to each parotid gland

Interventions

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

Primary outcome measure

Change from Baseline to Month 12 in Xerostomia-specific Questionnaire (XQ) Total Score [ Time Frame: 12 months ]

Central Contacts and Locations

More Information

Sponsor

MeiraGTx, LLC

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-13. This information was provided to ClinicalTrials.gov by MeiraGTx, LLC on 2026-07-24.