Long-term Follow-up of Gene Therapy for Radiation-Induced 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 — GENETIC
  Administration of a prespecified concentration of AAV2-hAQP1 via Stensen's duct to each parotid gland

Study Details

This study will assess the long-term safety and efficacy of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.

Key Dates

Start date

Aug 2, 2024

Status verified

Oct 2025

Primary completion

Feb 29, 2032

Completion

Feb 29, 2032

Study Design

Enrollment

276 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Follow-up group
  Participants who were randomized to AAV2-hAQP1 treatment in Study MGT-AQP1-201 will continue in this long-term follow-up schedule to complete an additional 48 months of follow-up after their end-of-study visit in Study MGT-AQP1-201. All study participants are to be followed for a period of 60 months after vector administration.
• Experimental: Active treatment group
  Participants who were randomized to placebo treatment in Study MGT-AQP1-201, will be offered to transition from the long-term follow-up schedule to an active treatment schedule at the time of unblinding. Study drug administration should be completed after unblinding and after confirmation of the participant's continued eligibility for treatment. Upon completion of the 12-month primary treatment period, participants will continue in the study according to a follow-up schedule, to complete a total of 60 months of follow-up after AAV2-hAQP1 administration.

Primary Outcome Measure

Number of participants with study drug-related adverse events and serious adverse events [ Time Frame: From study start until Month 60 post-treatment ]

Locations (7)

Find similar trials in Gilbert, AZ

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• A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
  PHASE2 · Recruiting · MeiraGTx, LLC · Gilbert, Arizona