Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin

Plain-language summary

This study looks at how COL7A1 gene therapy (beremagene geperpavec, BVEC) affects the recurrence of squamous cell carcinoma (SCC) in the skin of people with recessive dystrophic epidermolysis bullosa (RDEB). People aged 18 and older with RDEB confirmed by COL7A1 mutations and biopsy-proven SCC can take part. It is a Phase 2 study and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Recruiting

Sponsor

Stanford University

Intervention

BVEC

Start date

3/28/2025

Estimated completion

2/1/2027

Countries

United States, Italy

Related genes

Locations

• Redwood City, United States
• Bari, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.