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

Conditions

• CAR T Cell
• CAR T Cell Therapy

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Mar 31, 2026

Status verified

Feb 2026

Primary completion

Mar 31, 2041

Completion

Mar 31, 2041

Study Design

Enrollment

500 participants (estimated)

Primary Outcome Measure

Incidence of delayed adverse events [ Time Frame: 15 years post-final infusion of SCTx GTP ]

Central Contacts

• Adam Lamble
  206-987-2106
  [email protected]

Locations (1)

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