Long-Term Follow-Up of Subjects Treated With Seattle Children's Therapeutics Gene Therapy Products (LTFU-01)

Seattle Children's Healthcare System

Status: Not yet enrolling

Conditions: CAR T Cell Therapy; CAR T Cell

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

Study type: Observational

Funder types: Other

Identifiers

NCT07424157

LTFU-01

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.