A Long-Term Safety Follow-Up Study for Patients Treat With WU-CART-007

Condition(s) studied

Investigational drug(s) / intervention(s)

Genetic: WU-CART-007: No study drug is administered in this study. Patients who have received WU-CART-007 will be enrolled in this study for Long Term Safety and Efficacy

Study summary

This study will provide long-term follow-up for patients who have received treatment with WU-CART-007 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of WU-CART-007 for evaluation of delayed adverse events, presence of persisting WU-CART-007 vector sequences, and overall survival and progression-free survival.

Eligibility

Primary outcome measure(s)

• Delayed adverse events (AEs)/serious adverse events (SAEs) — up to 15 years
  assess the risk of delayed adverse events including serious events following exposure to WU-CART-007
• Persistence of WU-CART-007 cells — Every 6 months for up to 5 years and then yearly for up to 15 years
  Peripheral blood samples will be monitored used polymerase chain reaction for persistence of WU-CART-007 cells
• Tanner Staging — up to 15 years
  Tanner Staging will be used to evaluate growth and development outcomes and sexual maturity status for patients who were \< 18 years of age at the time of treatment with WU CART-007

Trial sites (5)

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