Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin | NCT06731933

Studies
Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin

NCT06731933

Sponsor

Stanford University

Status

Recruiting

Last Update Posted

Apr 20, 2026Actual

Enrollment

16Estimated

Phase

Phase 2

Conditions

Squamous Cell Carcinoma

Interventions

BVEC

Countries

United States
Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2025-09174	Registry Identifier	National Cancer Institute Clinical Trials Reporting Program

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 28, 2025Actual

Primary Completion Date

Feb 2027Estimated

Completion Date

Feb 2027Estimated

First Submitted Date

Dec 11, 2024

First Submission Date that Met QC Criteria

Dec 11, 2024

First Posted Date

Dec 13, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2026

Last Update Posted Date

Apr 20, 2026Actual

Name	Class
Epidermolysis Bullosa Research Partnership	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment with BVEC	Active Comparator		Drug: BVEC
No treatment with BVEC	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BVEC	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence rate of Squamous Cell Carcinoma	The outcome measure is recurrence rate of SCC following BVEC application at each SCC lesion	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations
Presence of biopsy proven squamous cell carcinoma (SCC)
Ability to understand and the willingness to provide written informed consent.
US based participants are willing to use beremagene geperpavec (BVEC)
Subject is 18 years or older
participant willingness to use an effective method of contraception

Exclusion Criteria:

Inability to travel to site for study visit
Subject is pregnant
Subject has Metastatic SCC's or is on any current systemic treatment for SCC.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kunju Sridhar	Contact	650-721-4902		kunju@stanford.edu

Overall Officials

Name	Affiliation	Role
Peter Marinkovich, MD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University	Recruiting	Redwood City	California	94063	United States

Condition Browse Module

MeSH Terms

ID	Term
D002294	Carcinoma, Squamous Cell

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided