Clinical Research Directory
Browse clinical research sites, groups, and studies.
Long-Term Follow-Up of Subjects Treated With Seattle Children's Therapeutics Gene Therapy Products
Sponsor: Seattle Children's Hospital
Summary
Subjects exposed to gene therapy products (GTPs) may be at risk for delayed or long-term adverse events. This is a long-term follow-up (LTFU) protocol designed to evaluate the long-term safety of Seattle Children's Therapeutics (SCTx) GTPs and incorporates in monitoring guidance from the U.S. Food and Drug Administration (FDA). Subjects will be followed for up to 15 years starting from the date of the most recent infusion of an SCTx GTP. Subjects planning to receive, or who have received, at least one infusion of an SCTx GTP will be offered participation in this LTFU study. Subjects enrolled in this study will have safety assessments and laboratory evaluations performed at scheduled intervals for each unique SCTx GTP received. No treatment is administered in this LTFU study.
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2026-03-31
Completion Date
2041-03-31
Last Updated
2026-02-20
Healthy Volunteers
No
Conditions
Interventions
Long term follow up in all patients who received an SCTx gene therapy product
Participants will be followed for 15 years following the receipt of their final infusion on a separate SCTx gene therapy protocol to monitor for the long term effects of CAR T cell therapy
Locations (1)
Seattle Children's Hospital
Seattle, Washington, United States