NCT06544798|Enrolling By InvitationPhase 2DMCFDA Drug
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
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Sponsor study identifier
interventional
276
2 countries
8
Study Start
August 2, 2024
Actual (reported)Primary Completion
February 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2, 2024
Actual (reported)August 5, 2024
Actual (reported)August 9, 2024
Actual (reported)February 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Number of participants with study drug-related adverse events and serious adverse events
From study start until Month 60 post-treatment
Participants who were randomized to AAV2-hAQP1 treatment in Study MGT-AQP1-201 will continue in this long-term follow-up schedule to complete an additional 48 months of follow-up after their end-of-study visit in Study MGT-AQP1-201. All study participants are to be followed for a period of 60 months after vector administration.
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.
Administration of a prespecified concentration of AAV2-hAQP1 via Stensen's duct to each parotid gland
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Miami Cancer Institute at Baptist Health South Florida
Miami, Florida, 33176, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Missouri
Columbia, Missouri, 65212, United States
Erie County Medical Center
Buffalo, New York, 14215, United States
Atrium Health
Charlotte, North Carolina, 28209, United States
Alleghany General Hospital
Pittsburgh, Pennsylvania, 15212, United States
First Submitted
August 5, 2024
First Posted
August 9, 2024
Study Start
August 2, 2024
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
Shirley and Jim Fielding Northeast Cancer Centre - Health Sciences North
Greater Sudbury, Ontario, P3E 5J1, Canada
February 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 16, 2025
Record last verified: 2025-10
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Source: ClinicalTrials.gov.
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