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

NCT07424157 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-06-25

No results posted yet for this study

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.

Conditions

  • CAR T Cell
  • CAR T Cell Therapy

Interventions

OTHER

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

Sponsors & Collaborators

  • Seattle Children's Hospital

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2041-03-31
Completion
2041-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07424157 on ClinicalTrials.gov