NCT05926765

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: MeiraGTx, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
GENETIC	AAV2-hAQP1 Concentration 1	Administration of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland
GENETIC	AAV2-hAQP1 Concentration 2	Administration of concentration 2 of AAV2-hAQP1 via Stensen's duct to each parotid gland
OTHER	Placebo	Administration of diluent via Stensen's duct to each parotid gland
GENETIC	AAV2-hAQP1 Concentration 3	Administration of concentration 3 of AAV2-hAQP1 via Stensen's duct to each parotid gland
GENETIC	AAV2-hAQP1 Concentration 4	Administration of concentration 4 of AAV2-hAQP1 via Stensen's duct to each parotid gland

Timeline

• Start date: 2023-06-13
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-07-03
• Last updated: 2026-02-02

Locations

33 sites across 3 countries: United States, Canada, United Kingdom

Regulatory

• FDA-regulated drug study