Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07424157

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

CAR T Cell CAR T Cell Therapy

Sex eligibility

All sexes

Study type

Observational

Primary location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location status: Recruiting

Location contact

Adam Lamble

CONTACT

[email protected]

206-987-2106

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Long term follow up in all patients who received an SCTx gene therapy product

Other

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

Primary outcomes

  1. 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.

  2. Long-term persistence of SCTx Gene Therapy Products

    Time frame: 15 years post-final infusion

    Monitor for long-term persistence of SCTx GTPs.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Adam Lamble

CONTACT

[email protected]

206-987-2106

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Registry information

Acronym: LTFU-01

Important dates

Study start
2026
Primary completion
2041
Study completion
2041
First posted
Feb 20, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.