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Gene therapy for ear tumors: Long-Term safety under review

NCT ID NCT07503613

Disease control Sponsor: Akouos, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study follows 100 people with vestibular schwannoma (a non-cancerous ear tumor) who previously received a gene therapy called AAVAnc80-antiVEGF. Researchers will monitor for late side effects and measure tumor size changes over time using MRI scans. The goal is to understand the long-term safety and whether the therapy keeps working.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AAVAnc80-antiVEGF gene therapy
What this could lead to
If successful, this could show that a single gene therapy injection safely controls tumor growth and reduces the need for repeated treatments.
What could go wrong
This is an observational follow-up study, not a new treatment test. It may reveal long-term risks like new tumors or immune problems, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Apr 2040

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Individuals with vestibular schwannoma who received an intracochlear administration of AAVAnc80-antiVEGF in an interventional clinical trial.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: -Individual with vestibular schwannoma who received an intracochlear administration of AAVAnc80-antiVEGF in an interventional clinical trial. -Participant willingness to comply with all study requirements as evidenced by successful completion of the informed consent process. Exclusion Criteria: -Any condition that would not allow the potential participant to complete follow-up examinations during the course of the study and/or, in the opinion of the Investigator, makes the potential participant unsuitable for the study.

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Conditions

The condition(s) this trial relates to.

acoustic neuroma hearing loss disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Vestibular schwannoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Texas Southwestern

    Dallas, Texas, 75390, United States

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