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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AAV2-hAQP1 Concentration 1 — GENETIC
  Administration of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland
• AAV2-hAQP1 Concentration 2 — GENETIC
  Administration of concentration 2 of AAV2-hAQP1 via Stensen's duct to each parotid gland
• Placebo — OTHER
  Administration of diluent via Stensen's duct to each parotid gland
• AAV2-hAQP1 Concentration 3 — GENETIC
  Administration of concentration 3 of AAV2-hAQP1 via Stensen's duct to each parotid gland
• AAV2-hAQP1 Concentration 4 — GENETIC
  Administration of concentration 4 of AAV2-hAQP1 via Stensen's duct to each parotid gland

Study Details

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.

Key Dates

Start date

Jun 13, 2023

Status verified

Jan 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

276 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1: AAV2-hAQP1 Group 1
  Eligible participants will receive up to 3 mL of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland
• Experimental: Cohort 1: AAV2-hAQP1 Group 2
  Eligible participants will receive up to 3 mL of concentration 2 of AAV2-hAQP1 via Stensen's duct to each parotid gland
• Placebo Comparator: Cohort 1: Placebo group
  Eligible participants will receive up to 3 mL of diluent via Stensen's duct to each parotid gland
• Experimental: Cohort 2: AAV2-hAQP1 Group 3
  Eligible participants will receive up to 3 mL of concentration 3 of AAV2-hAQP1 via Stensen's duct to each parotid gland
• Experimental: Cohort 2: AAV2-hAQP1 Group 4
  Eligible participants will receive up to 3 mL of concentration 4 of AAV2-hAQP1 via Stensen's duct to each parotid gland
• Placebo Comparator: Cohort 2 Placebo group
  Eligible participants will receive up to 3 mL of diluent via Stensen's duct to each parotid gland

Primary Outcome Measure

Change from Baseline to Month 12 in Xerostomia-specific Questionnaire (XQ) Total Score [ Time Frame: 12 months ]

Central Contacts

• MeiraGTx Clinical Project Manager
  646-860-7982
  [email protected]

Locations (18)

Find similar trials in Gilbert, AZ

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• Long-term Follow-up of Gene Therapy for Radiation-Induced Xerostomia
  PHASE2 · Enrolling By Invitation · MeiraGTx, LLC · Gilbert, Arizona