Long-Term Follow-Up of Subjects Treated With Seattle Children's Therapeutics Gene Therapy Products

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.

NCT Number	NCT07424157
Lead Sponsor	Seattle Children's Hospital
Conditions	CAR T Cell, CAR T Cell Therapy
Enrollment	500 participants
Start Date	2026-06-15
Primary Completion	2041-03-31 (estimated)
Study Completion	2041-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-25