A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia

PHASE2RecruitingINTERVENTIONAL
Enrollment

276

Participants

Timeline

Start Date

June 13, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

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

AAV2-hAQP1 Concentration 1

Administration of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland

GENETIC

AAV2-hAQP1 Concentration 2

Administration of concentration 2 of AAV2-hAQP1 via Stensen's duct to each parotid gland

OTHER

Placebo

Administration of diluent via Stensen's duct to each parotid gland

GENETIC

AAV2-hAQP1 Concentration 3

Administration of concentration 3 of AAV2-hAQP1 via Stensen's duct to each parotid gland

GENETIC

AAV2-hAQP1 Concentration 4

Administration of concentration 4 of AAV2-hAQP1 via Stensen's duct to each parotid gland

Trial Locations (25)

14215

RECRUITING

Erie County Medical Center, Buffalo

15212

RECRUITING

Alleghany General Hospital, Pittsburgh

17033

RECRUITING

Penn State, Hershey

21231

RECRUITING

Johns Hopkins Hospital, Baltimore

27514

RECRUITING

UNC-Chapel Hill, Chapel Hill

28203

RECRUITING

Atrium Health, Charlotte

33176

RECRUITING

Miami Cancer Institute at Baptist Health South Florida, Miami

48202

RECRUITING

Henry Ford Health, Detroit

52242

RECRUITING

University of Iowa, Iowa City

60611

RECRUITING

Northwestern Memorial Hospital, Chicago

65212

RECRUITING

University of Missouri, Columbia

75390

RECRUITING

UT Southwestern Medical Center, Dallas

77030

RECRUITING

Houston Methodist, Houston

85234

RECRUITING

Banner MD Anderson Cancer Center, Gilbert

91010

RECRUITING

City of Hope, Duarte

02120

RECRUITING

Brigham and Women's Hospital, Boston

P3E 5J1

RECRUITING

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

Unknown

RECRUITING

Hopital Fleurimont, CIUSSS de l'Estrie-CHUS, Québec

RECRUITING

Princess Margaret Cancer Centre, Toronto

RECRUITING

Addenbrooke's Hospital, Cambridge

G8Z 3R9

RECRUITING

CIUSSS-MCQ (Trois-Rivières, QC), Trois-Rivières

DD1 9SY

RECRUITING

Ninewells Hospital & Medical School, Dundee

EH4 2XU

RECRUITING

Western General, London

SE1 9RT

RECRUITING

Guys Hospital, London

NG7 2UH

RECRUITING

Nottingham University Hospitals NHS Trust, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MeiraGTx, LLC

INDUSTRY