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
MeiraGTx, LLC
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Completed beam radiation therapy for head and neck cancer at least 3 years prior to the first screening visit * No history of recurrent head and neck cancer, parotid gland cancer, or a second primary cancer, except for treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma * An unstimulated whole saliva flow rate (mL/min) \>0 (i.e., at least one drop of saliva in the collection tube) * A stimulated whole saliva flow rate (mL/min) within a specified range after mechanical stimulation by chewing * Average screening XQ Total Score at or abov…
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 CenterGilbert, Arizona
- City of HopeDuarte, California
- Miami Cancer Institute at Baptist Health South FloridaMiami, Florida
- University of IowaIowa City, Iowa
- Johns Hopkins HospitalBaltimore, Maryland
- Tufts University School of Dental MedicineBoston, Massachusetts