NCT05509855

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

A Long-Term Safety Follow-Up Study for Patients Treated With Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007)

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 44 (estimated)
• Sponsor: Wugen, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• T-cell Acute Lymphoblastic Leukemia
• T-cell Lymphoblastic Lymphoma

Interventions

Type	Name	Description
GENETIC	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

Timeline

• Start date: 2022-08-22
• Primary completion: 2037-07-01
• Completion: 2037-07-01
• First posted: 2022-08-22
• Last updated: 2024-11-20

Locations

5 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study