Long-term Follow-up of Gene Therapy for Radiation-Induced Xerostomia

NCT06544798 · tracked via the Priya Life Science USA tracker

Sponsor

MeiraGTx, LLC

Phase

Phase 2

Started

2024-08-02

Last updated

2025-10-16

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

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

Study summary

This study will assess the long-term safety and efficacy 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

Inclusion Criteria: * Received study drug in Study MGT-AQP1-201 Exclusion Criteria: * Withdrew consent to participate in Study MGT-AQP1-201.

Primary outcome measure(s)

Number of participants with study drug-related adverse events and serious adverse events — From study start until Month 60 post-treatment

Trial sites (8)

Facility	City	Region
Banner MD Anderson Cancer Center	Gilbert	Arizona
Miami Cancer Institute at Baptist Health South Florida	Miami	Florida
University of Iowa	Iowa City	Iowa
University of Missouri	Columbia	Missouri
Erie County Medical Center	Buffalo	New York
Atrium Health	Charlotte	North Carolina
Alleghany General Hospital	Pittsburgh	Pennsylvania
Shirley and Jim Fielding Northeast Cancer Centre - Health Sciences North	Greater Sudbury	Ontario

More MeiraGTx, LLC trials in the USA

Long-term Follow-up of Glutamic Acid Decarboxylase (GAD) Gene Transfer in Parkinson's Disease Active, not recruiting

A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia Active, not recruiting

Long-Term Follow-Up Study of AAV2hAQP1 for Radiation Induced Xerostomia Active, not recruiting

Other trials for the same condition

A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia Active, not recruiting

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 NCT06544798 on ClinicalTrials.gov ↗ ← All trials in the USA