Gene therapy to reduce skin cancer recurrence in patients with a specific genetic condition
Impact of Collagen VII Gene Therapy on Squamous Cell Carcinoma Recurrence in Recessive Dystrophic Epidermolysis Bullosa Skin
This study is testing a new gene therapy to see if it can help people with a specific skin condition reduce the chances of skin cancer coming back after treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 2 sites (Redwood City, California and 1 other locations) |
| Trial ID | NCT06731933 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of BVEC-induced COL7A1 gene therapy in patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB) who have undergone excision of Squamous Cell Carcinoma (SCC). The therapy is designed to normalize the tumor microenvironment, potentially reducing the likelihood of cancer recurrence. Participants will be monitored for changes in tumor behavior and overall skin health following treatment. The study is interventional and is currently in Phase 2.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with RDEB who have biopsy-proven SCC and are willing to participate in the treatment protocol.
Not a fit: Patients with metastatic SCC or those currently receiving systemic treatment for SCC may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce the recurrence of skin cancer in RDEB patients, potentially extending their lifespan.
How similar studies have performed: While gene therapy approaches are being explored in various contexts, this specific application in RDEB and SCC is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Redwood City, California and 1 other locations
- Stanford University — Redwood City, California, United States (Recruiting)
- Azienda Ospedliero-Universitaia — Bari, Italy (Recruiting)
Study contacts
- Principal investigator: Peter Marinkovich, MD — Stanford University
- Study coordinator: Kunju Sridhar
- Email: kunju@stanford.edu
- Phone: 650-721-4902
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.