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

Recruiting now

Conditions studied: CAR T Cell, CAR T Cell Therapy

In brief

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 facts

Study ID

NCT07424157

Run by

Seattle Children's Hospital

People needed

500

Starts

2026-06-15

Expected to finish

2041-03-31

Last updated by the study team

2026-06-25

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Enrolled in an SCTx GTP clinical trial;
• Received or planned to receive an SCTx GTP;
• Subject and/or legally authorized representative have provided consent/assent for study participation.

Where it is running

• Seattle Children's Hospital — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.