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NCT05509855 Clinical Trial

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

T-cell Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05509855
Other study ID # WUC007-02
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date August 22, 2022
Est. completion date July 1, 2037

Study information
Verified date September 2023
Source Wugen, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 44
Est. completion date July 1, 2037
Est. primary completion date July 1, 2037
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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

Related Conditions & MeSH terms

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

Intervention

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

Locations
Country Name City State
Australia Peter MacCullam Cancer Center Melbourne
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Washington University Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Wugen, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Secondary Overall survival (OS) To evaluate survival n patients previously treated with WU-CART-007 up to 15 years
Secondary Progression-free survival (PFS) To evaluate profession free survival in patients previously treated with WU-CART-007 up to 15 years
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