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A Long-Term Safety Follow-Up Study for Patients Treated With Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007)
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.
This long-term follow-up (LTFU) study is designed to follow patients for up to 15 years after WU-CART-007 infusion to evaluate the persistence of the WU-CART-007 cell clones and to explore any unanticipated genetic consequences secondary to the introduction of genetically modified cells. Long-term toxicity, subsequent anti-cancer therapy, and survival status will be monitored. Patients will transition to this LTFU study when they meet the criteria for discontinuation from the main study or after completing 24 months of follow-up in the main study. Patients will be contacted every 6 months for the first 5 years following WU-CART-007 administration and then yearly, for up to 10 years, for a total of 15 years of follow-up after prior WU-CART-007 treatment or until death, whichever occurs first. Patients will be evaluated either at the treating site or by the patient's primary Health Care Provider (HCP). Patients will be required to allow key sponsor contacts to continue to access medical records so that information related to their health condition and initial treatment response may be obtained.
Age
12 - No limit years
Sex
ALL
Healthy Volunteers
No
City of Hope
Duarte, California, United States
Childrens Hospital LA
Los Angeles, California, United States
Washington University
St Louis, Missouri, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Peter MacCullam Cancer Center
Melbourne, Australia
Start Date
August 22, 2022
Primary Completion Date
July 1, 2037
Completion Date
July 1, 2037
Last Updated
November 20, 2024
44
ESTIMATED participants
Genetic: WU-CART-007
GENETIC
Lead Sponsor
Wugen, Inc.
NCT05376111
NCT05679895
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06934382