Clin2
NCT07697118Worth exploringNot yet recruiting

Gene therapy trial for IPEX syndrome

The Immune Dysregulation Polyendocrinopathy Enteropathy X-linked Syndrome is a Primary Immunodeficiency Caused by Pathogenic Variants in Forkhead Box Protein 3

Part of Genetic & congenital, Immune system & allergy clinical trials.

This trial tests a gene therapy that adds a working FOXP3 gene to your own T cells to help them regulate your immune system. It's for people with IPEX syndrome whose disease is not controlled by standard treatments or who cannot have a stem cell transplant.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1/Phase 2
Enrollment
5 people
Ages
1 year to 45 years
Study type
Interventional

Who can take part

  • You must be male and between 1 and 45 years old (the first three people treated will be 10 to 45).
  • You have IPEX syndrome caused by a change in the FOXP3 gene.
  • Your IPEX symptoms keep coming back even though you're on immune-suppressing medicines.
  • A stem cell transplant is not possible or a suitable donor isn't available.
  • You agree to use effective birth control for at least 12 months after the infusion.
  • You are willing to come back for check-ups for 2 years and then for long-term follow-up for 15 years.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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