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Gene therapy gel aims to stop skin cancer from coming back in RDEB patients

NCT ID NCT06731933

Disease control Sponsor: Stanford University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase 2 trial tests whether a gene therapy gel called BVEC can reduce the return of squamous cell carcinoma (a type of skin cancer) in people with recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic condition that causes fragile, blistering skin. The gel is applied to the skin after cancer removal to try to normalize the tissue and prevent recurrence. The study involves 16 adults in the US and Italy.

What this could mean

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

Active substance
Beremagene geperpavec (BVEC) - a gene therapy gel applied to the skin
What this could lead to
If it works, this could reduce the chance of skin cancer coming back after surgery in people with RDEB, potentially extending their lives.
What could go wrong
This is a small early-phase trial with only 16 people, so results may not apply to everyone. The gel is only tested on specific skin spots, and it may not prevent new cancers elsewhere.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 16 people

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

Started

Mar 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

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: 1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations 2. Presence of biopsy proven squamous cell carcinoma (SCC) 3. Ability to understand and the willingness to provide written informed consent. 4. US based participants are willing to use beremagene geperpavec (BVEC) 5. Subject is 18 years or older 6. participant willingness to use an effective method of contraception Exclusion Criteria: 1. Inability to travel to site for study visit 2. Subject is pregnant 3. Subject has Metastatic SCC's or is on any current systemic treatment for SCC.

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Conditions

The condition(s) this trial relates to.

recessive dystrophic epidermolysis bullosa squamous cell carcinoma

As listed by the trial registrant

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

Squamous cell carcinoma

How to take part

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

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Azienda Ospedliero-Universitaia

    RECRUITING

    Bari, Italy

  • Stanford University

    RECRUITING

    Redwood City, California, 94063, United States

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