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Gene Therapy Trial Browser
Clinical Trial Report
Gene Therapy Trial Report
Summary
A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
NCTID
NCT05926765
(View at clinicaltrials.gov)
Description
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.
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Indication
Radiation-induced Xerostomia
Compound Name
AAV-hAQP1
Sponsor
MeiraGTx, LLC
Funder Type
Industry
Status
Recruiting
Enrollment Count
120
Therapy Information
Target Gene/Variant
AQP1
Therapy Type
Gene transfer
Therapy Route
In-vivo
Mechanism of Action
Overexpression of protective allele/gene
Route of Administration
Parotid
Drug Product Type
Viral vector
Target Tissue/Cell
Delivery System
Viral transduction
Vector Type
AAV2
Editor Type
Dose 1
0.4 x 10^12 vg/gland
Dose 2
1.2 x 10^12 vg/gland
Dose 3
Dose 4
Dose 5
Study Record Dates
Current Stage
Phase2
Submit Date
2023-06-22
Completion Date
2025-07
Last Update
2024-10-08
Participation Criteria
Eligible Age
>=18 Years
Standard Ages
Adult, Older adult
Eligible Sex
ALL
Locations
No.of Trial Sites
22
Locations
Canada,United States,United Kingdom
Regulatory Information
Has US IND
True
Recent Updates
FDA in support of Phase II study as pivotal for BLA submission
Resources/Links
Patents
WO2024079655A1
WO2024079657A1
Clinical Publications
https://investors.meiragtx.com/static-files/ba644eb0-16b6-444f-bcb3-c6e9cb6fe4fa
News and Press Releases
https://investors.meiragtx.com/news-releases/news-release-details/meiragtx-reports-first-quarter-2024-financial-and-operational