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

• Conditions: T-cell Lymphoblastic Lymphoma; T-cell Acute Lymphoblastic Leukemia

• Registration Number: NCT05509855
• Lead Sponsor: Wugen, Inc.

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-08-18
• Study Start: 2022-08-22
• Study First Posted: 2022-08-22
• Status Verified: 2024-09
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Primary Completion: 2037-07-01
• Study Completion: 2037-07-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Patients that received WU-CART-007 in the context of any investigational study will be eligible to participate in this long-term follow-up study.

Exclusion Criteria

Not Applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	up to 15 years	To evaluate survival n patients previously treated with WU-CART-007
Progression-free survival (PFS)	up to 15 years	To evaluate profession free survival in patients previously treated with WU-CART-007

Trial Locations

Locations (5)

Peter MacCullam Cancer Center; 🇦🇺 Melbourne, Australia

City of Hope; 🇺🇸 Duarte, California, United States

Childrens Hospital LA; 🇺🇸 Los Angeles, California, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States