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RECRUITING Phase 2

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

NCT05926765 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • OTHER Placebo
  • GENETIC AAV2-hAQP1 Concentration 1
  • GENETIC AAV2-hAQP1 Concentration 2
  • GENETIC AAV2-hAQP1 Concentration 3
  • GENETIC AAV2-hAQP1 Concentration 4

Study Locations (20)

Massachusetts

  • Tufts University School of Dental Medicine — Boston
  • Brigham and Women's Hospital — Boston

Missouri

  • University of Missouri — Columbia
  • Washington University - St. Louis — St Louis

North Carolina

  • UNC-Chapel Hill — Chapel Hill
  • Atrium Health — Charlotte

Pennsylvania

  • Penn State — Hershey
  • Alleghany General Hospital — Pittsburgh

Texas

  • UT Southwestern Medical Center — Dallas
  • Houston Methodist — Houston

Arizona

  • Banner MD Anderson Cancer Center — Gilbert

California

  • City of Hope — Duarte

Florida

  • Miami Cancer Institute at Baptist Health South Florida — Miami

Trial Details

FieldValue
Enrollment Target 276 participants
Start Date 2023-06-13
Est. Completion 2026-12
Phase Phase 2

Sponsor

MeiraGTx

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05926765

The ClinicalTrials.gov registry entry for NCT05926765 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 276 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MeiraGTx, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands appearing as the primary indexed condition, and to 5 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05926765 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Massachusetts, Missouri, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05926765 about?

NCT05926765 is a clinical study titled "A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia". 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.

What is the current status of trial NCT05926765?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 276 participants. The study started on 2023-06-13. Estimated completion is 2026-12.

What conditions does trial NCT05926765 study?

This clinical trial studies the following conditions: Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05926765?

The interventions under investigation include: Placebo (OTHER), AAV2-hAQP1 Concentration 1 (GENETIC), AAV2-hAQP1 Concentration 2 (GENETIC), AAV2-hAQP1 Concentration 3 (GENETIC), AAV2-hAQP1 Concentration 4 (GENETIC). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05926765?

This trial is sponsored by MeiraGTx, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05926765 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Iowa, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial