RecruitingPhase 2NCT06731933

Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin

Impact of Collagen VII Gene Therapy on Squamous Cell Carcinoma Recurrence in Recessive Dystrophic Epidermolysis Bullosa Skin


Sponsor

Stanford University

Enrollment

16 participants

Start Date

Mar 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study objective is to see if BVEC induced C7 expression in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin following Squamous cell carcinoma (SCC) excision will normalize the invasive tumor microenvironment and reduce tumor recurrence. Prevention of SCC's in the RDEB subjects will increase their life span.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether a gene therapy called beremagene geperpavec (BVEC, which restores the COL7A1 gene) reduces the return or recurrence of squamous cell carcinoma (SCC) — a dangerous skin cancer — in people with recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic skin-blistering disease. **You may be eligible if...** - You have a confirmed diagnosis of generalized recessive dystrophic epidermolysis bullosa (RDEB) with COL7A1 gene mutations - You have a biopsy-confirmed squamous cell carcinoma - You are 18 or older and based in the US - You are willing to use beremagene geperpavec (BVEC) treatment - You are able to use an effective method of contraception **You may NOT be eligible if...** - You are unable to travel to the study site for visits - You are pregnant - Your SCC has spread to other parts of the body (metastatic), or you are currently on systemic treatment for SCC Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBVEC

The study drug will be administered by home nurse at Subjects home for the participants residing in US. No drug will be applied when at study site. The subjects enrolled in Bari, Italy will not be administered BVEC.


Locations(2)

Stanford University

Redwood City, California, United States

Azienda Ospedliero-Universitaia

Bari, Italy

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NCT06731933


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