NCT05509855
A Long-Term Safety Follow-Up Study for Patients Treat With WU-CART-007
Enrolling by Invitation
Not specifiedAges 12+ObservationalWugen, Inc.
~44 participants
Updated 2024-11-20 on ClinicalTrials.gov
What's tested:Genetic: WU-CART-007
At a glance
Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Delayed adverse events (AEs)/serious adverse events (SAEs)
Measured over up to 15 years
+2 more outcomes measured
Conditions
Where it's being run
5 sites across 4 statesCalifornia2
Missouri1
Pennsylvania1
Australia1
Study leadership
- Cherry Thomas, MD · STUDY_DIRECTOR · Wugen, Inc.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- 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 cellsEvery 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 Stagingup 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