NCT05509855|Enrolling By InvitationFDA Drug
Loading search results
Sponsor study identifier
observational
44
2 countries
5
Study Start
August 22, 2022
Actual (reported)Primary Completion
July 1, 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 1, 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 20, 2022
Actual (reported)August 22, 2022
Actual (reported)August 22, 2022
Actual (reported)July 1, 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 1, 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Delayed adverse events (AEs)/serious adverse events (SAEs)
assess the risk of delayed adverse events including serious events following exposure to WU-CART-007
up to 15 years
Persistence of WU-CART-007 cells
Peripheral blood samples will be monitored used polymerase chain reaction for persistence of WU-CART-007 cells
Every 6 months for up to 5 years and then yearly for up to 15 years
Tanner Staging
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
up to 15 years
Overall survival (OS)
up to 15 years
Progression-free survival (PFS)
up to 15 years
Patients who received previous treatment with 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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The patient population will consist of patients who participated in a previous clinical trial where WU-CART-007 was administered.
Contact the study team to confirm eligibility.
City of Hope
Duarte, California, 91010, United States
Childrens Hospital LA
Los Angeles, California, 90027, United States
Washington University
St Louis, Missouri, 63110, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Peter MacCullam Cancer Center
Melbourne, Australia
Test for replication-competent lentivirus (RCL) and cellular persistence following treatment with WU-CART-007 will be performed until cells are undetectable.
Cherry Thomas, MD
Allotera Therapeutics
First Submitted
July 20, 2022
First Posted
August 22, 2022
Study Start
August 22, 2022
Actual (reported)Primary Completion
July 1, 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 1, 2037
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 20, 2024
Record last verified: 2024-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: