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Enrolling by Invitation

NCT Number: NCT06544798

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

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.

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Key information

Conditions

Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shirley and Jim Fielding Northeast Cancer Centre - Health Sciences North, Greater Sudbury, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Received study drug in Study MGT-AQP1-201

Exclusion criteria

  • Withdrew consent to participate in Study MGT-AQP1-201.

Treatment and study plan

AAV2-hAQP1

Genetic

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

Primary outcomes

  1. Number of participants with study drug-related adverse events and serious adverse events

    Time frame: From study start until Month 60 post-treatment

Sponsors and collaborators

Lead sponsor

MeiraGTx, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2032
Study completion
2032
First posted
Aug 9, 2024
Registry last updated
Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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