A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa

Plain-language summary

This study examines the cell-based gene therapy FCX-007 (dabocemagene autoficel) in patients with recessive dystrophic epidermolysis bullosa. It can enroll patients aged 2 and older with a clinical diagnosis of the disease confirmed by a COL7A1 gene mutation. It is being conducted in Phase 3 and is currently not recruiting but still ongoing (active, not recruiting).

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Active, not recruiting

Sponsor

Castle Creek Biosciences, LLC.

Intervention

FCX-007 (dabocemagene autoficel; see below for FCX-007 description)

Start date

6/9/2020

Estimated completion

7/1/2037

Countries

United States

Related genes

Locations

• Stanford, United States
• Aurora, United States
• Jacksonville, United States
• Rochester, United States
• Austin, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Key Inclusion Criteria:

* Male or female ≥2 years of age at the Screening visit.
* Clinical diagnosis of RDEB with confirmation of COL7A1 genetic mutation.

Key Exclusion Criteria:

* Medical instability limiting ability to travel to the investigative site.
* Active infection with human immunodeficiency virus, hepatitis B or hepatitis C.
* The presence of COL7 antibodies.
* Evidence of systemic infection.
* Evidence or history of squamous cell carcinoma at the site to be injected.
* Evidence of or history of metastatic squamous cell carcinoma.
* Known allergy to any of the constituents of the product.
* Female who is pregnant or breastfeeding.
* Receipt of a chemical or biological intervention for the specific treatment of RDEB in the past three (3) months prior to screening or anticipated/planned during the screening and treatment period for this study.