Clinical trial · Interventional
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
NCT06731933CI-TRIAL-00108818recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BVEC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Treatment with BVEC
- interventionNames
- Drug: BVEC
- type
- NO_INTERVENTION
- label
- No treatment with BVEC
Primary outcomes (1)
- measure
- Recurrence rate of Squamous Cell Carcinoma
- timeFrame
- 2 years
- description
- The outcome measure is recurrence rate of SCC following BVEC application at each SCC lesion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.