Recruiting

SCTx GTPs

Sponsor:

Seattle Children's Hospital

Code:

NCT07424157

Conditions

CAR T Cell

CAR T Cell Therapy

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

CAR T Cell

CAR T Cell Therapy

Study ID

NCT07424157

Start date

Jun 15, 2026

Status verified date

Feb, 2026

Completion date

Mar 31, 2041

Anticipated

Primary completion date

Mar 31, 2041

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

Primary outcome measure

  • Incidence of delayed adverse events [ Time Frame: 15 years post-final infusion of SCTx GTP ]
  • Long-term persistence of SCTx Gene Therapy Products [ Time Frame: 15 years post-final infusion ]
  • Long-term clinical outcomes following treatment with SCTx GTP [ Time Frame: 15 years post-final infusion ]

Central Contacts and Locations

Central contacts

Adam Lamble

206-987-2106CBDCIntake@seattlechildrens.org

Locations

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Adam Lamble

206-987-2106CBDCIntake@seattlechildrens.org

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Jun 25, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2026-06-25.