RecruitingPhase 2NCT05926765

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

A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia

Sponsor

MeiraGTx, LLC

Enrollment

276 participants

Start Date

Jun 13, 2023

Study Type

INTERVENTIONAL

Conditions

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

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a gene therapy (AAV2-hAQP1) delivered directly into the salivary glands to treat severe dry mouth caused by radiation therapy for head and neck cancer. **You may be eligible if...** - You completed radiation therapy for head and neck cancer at least 3 years ago - You still produce at least a small amount of saliva - You have significant dry mouth symptoms - Your head and neck cancer has not come back (confirmed by recent scans and exam) - You have tried or considered prescription medications for dry mouth **You may NOT be eligible if...** - Your head and neck cancer has recurred - You have an autoimmune disease affecting the salivary glands (like Sjogren's syndrome) - You are on immune-suppressing medications - You have active hepatitis C or HIV - You smoke or have smoked in the last 3 years - You have a history of a specific type of glaucoma (angle-closure glaucoma) - You have poorly controlled diabetes (HbA1c above 7%) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICAAV2-hAQP1 Concentration 1

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

GENETICAAV2-hAQP1 Concentration 2

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

OTHERPlacebo

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

GENETICAAV2-hAQP1 Concentration 3

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

GENETICAAV2-hAQP1 Concentration 4

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

Locations(33)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

City of Hope

Duarte, California, United States

Miami Cancer Institute at Baptist Health South Florida

Miami, Florida, United States

University of Iowa

Iowa City, Iowa, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Henry Ford Health

Detroit, Michigan, United States

University of Missouri

Columbia, Missouri, United States

Washington University - St. Louis

St Louis, Missouri, United States

Erie County Medical Center

Buffalo, New York, United States

UNC-Chapel Hill

Chapel Hill, North Carolina, United States

Atrium Health

Charlotte, North Carolina, United States

Penn State

Hershey, Pennsylvania, United States

Alleghany General Hospital

Pittsburgh, Pennsylvania, United States

Johnson City Medical Center

Johnson City, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Houston Methodist

Houston, Texas, United States

Shirley and Jim Fielding Northeast Cancer Centre - Health Sciences North

Greater Sudbury, Ontario, Canada

Hopital Fleurimont, CIUSSS de l'Estrie-CHUS

Québec, Canada

Princess Margaret Cancer Centre

Toronto, Canada

CIUSSS-MCQ (Trois-Rivières, QC)

Trois-Rivières, Canada

Addenbrooke's Hospital

Cambridge, United Kingdom

Cardiff and Vale NHS Trust - Head & Neck Services

Cardiff, United Kingdom

Ninewells Hospital & Medical School

Dundee, United Kingdom

Glasgow Royal Infirmary

Glasgow, United Kingdom

Leeds Dental Institute

Leeds, United Kingdom

Western General

London, United Kingdom

Guys Hospital

London, United Kingdom

The Royal Marsden

London, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

York Hospital

York, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05926765