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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.
(Show More)
Development Status
Active
Indication
Grade 2 and 3 Radiation-Induced Late Xerostomia
Disease Ontology Term
DOID:10854
Compound Name
AAV-hAQP1
Sponsor
MeiraGTx, LLC
Funder Type
Industry
Recruitment Status
Recruiting
Enrollment Count
120
Results Posted
Not Available
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
none
Dose 1
0.4E12 vg/gland
Dose 2
1.2E12 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
Sexes Eligible for Study
ALL
Locations
No.of Trial Sites
22
Locations
Canada,United States,United Kingdom
Regulatory Information
Has US IND
True
FDA Designations
Orphan Drug Designation, Regenerative Medicine Advanced Therapy
Recent Updates
FDA in support of Phase II study as pivotal for BLA submission
Resources/Links
Clinical Publications
(Presentation) Results of a Phase 1, Open-label, Dose-escalation Study of Gene Therapy with AAV2-hAQP1 as Treatment for Grade 2 and 3 Radiation-induced Late Xerostomia and Parotid Gland Hypofunction - AAOM 2024
News and Press Releases
MeiraGTx Granted FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for AAV2-hAQP1 for the Treatment of Grade 2/3 Radiation-Induced Xerostomia
Related NCTID
Long Term Follow-Up: NCT06544798