Clin2
NCT03311503Possibly a fitRecruiting

Gene therapy for X-linked SCID in young children

Severe Combined Immunodeficiency, X LinkedGene Therapy

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

This trial tests a gene therapy using a lentivirus to give missing immune system instructions in children with X-linked SCID (SCID-X1). It also uses a low dose of targeted chemotherapy (busulfan) to help the new genes work, and it requires long-term follow-up for safety.

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

Phase
Phase 1/Phase 2
Enrollment
12 people
Ages
birth to 5 years
Study type
Interventional

Who can take part

  • Your child must have X-linked SCID (SCID-X1) caused by a confirmed IL2RG gene change and very weak T-cell function
  • There must be no matching close family donor for a transplant (an HLA-identical related donor)
  • Your child must be 8 weeks to 5 years old when busulfan is given
  • You (and your child’s guardian) must sign consent, and you must be willing to return for long-term follow-up for 15 years
  • If your child previously had a related-donor transplant, they must show no donor T cells are still taking hold

View the official record on ClinicalTrials.gov

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