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Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin

Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin

Recruiting
18 years and older
All
Phase 2
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Overview

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

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.

Study details
    Squamous Cell Carcinoma

NCT06731933

Stanford University

23 April 2025

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