NCT06544798

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

Long-term Follow-up of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia

• Status: Enrolling By Invitation
• 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 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.

Detailed description

Individual participation in this study will last approximately 48 months for participants who received AAV2-hAQP1 in Study MGT-AQP1-201 and at least 60 months for participants who receive AAV2-hAQP1 in Study MGT-AQP1-202.

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

Timeline

• Start date: 2024-08-02
• Primary completion: 2032-02-01
• Completion: 2032-02-01
• First posted: 2024-08-09
• Last updated: 2025-10-16

Locations

8 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study