Current Research Studies

LONG-TERM FOLLOW-UP OF SUBJECTS TREATED WITH SEATTLE CHILDREN'S THERAPEUTICS GENE THERAPY PRODUCTS

LTFU-01

  • Condition(s): Liver, Other Skin, Non-Hodgkin's Lymphoma, Esophagus, Bones and Joints, Melanoma, Skin, Myeloid and Monocytic Leukemia, Mycosis Fungoides, Rectum, Small Intestine, Colon, Kidney, Eye and Orbit, Pancreas, Thyroid, Other Digestive Organ, Other Male Genital, Ill-Defined Sites, Anus, Ovary, Breast, Prostate, Brain and Nervous System, Cervix, Stomach, Other Endocrine System, Leukemia, other, Other Urinary, Corpus Uteri, Hodgkin's Lymphoma, Lymphoid Leukemia, Other Female Genital, Soft Tissue, Urinary Bladder, Lung, Larynx
  • Phase: N/A
  • Clinicaltrials.gov ID: NCT07424157

What is the goal of the study?

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 enter the LTFU-01 study a year after their most recent infusion on their parent GTP protocol and 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.

Who can participate in the study?

Please contact the study team listed below to learn more.

Study Team: