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

Phase 2

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

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Active treatment group	AAV2-hAQP1	Participants who were randomized to placebo treatment in Study MGT-AQP1-201, will be offered to transition from the long-term follow-up schedule to an active treatment schedule at the time of unblinding. Study drug administration should be completed after unblinding and after confirmation of the participant's continued eligibility for treatment. Upon completion of the 12-month primary treatment period, participants will continue in the study according to a follow-up schedule, to complete a total of 60 months of follow-up after AAV2-hAQP1 administration.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method

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