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Clinical Trials/NCT07424157
NCT07424157RecruitingNot Applicable

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

Seattle Children's Hospital1 site in 1 country500 target enrollmentStarted: June 15, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
500
Locations
1
Primary Endpoint
Incidence of delayed adverse events

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Incidence of delayed adverse events

Time Frame: 15 years post-final infusion of SCTx GTP

The type, frequency, severity, and duration of adverse events considered related to the SCTx gene therapy product (GTP) the participant received.

Long-term persistence of SCTx Gene Therapy Products

Time Frame: 15 years post-final infusion

Monitor for long-term persistence of SCTx GTPs.

Long-term clinical outcomes following treatment with SCTx GTP

Time Frame: 15 years post-final infusion

Death from any cause and first relapse following an initial remission

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Colleen Annesley

SCTx Medical Director

Seattle Children's Hospital

Study Sites (1)

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