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)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: T-cell Acute Lymphoblastic Leukemia; T-cell Lymphoblastic Lymphoma
• Intervention / Treatment: Genetic: Genetic: WU-CART-007

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 Type: Observational
• Enrollment (Estimated): 44

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia
    • Peter MacCullam Cancer Center
• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The patient population will consist of patients who participated in a previous clinical trial where WU-CART-007 was administered.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients treated with WU-CART-007; Patients who received previous treatment with WU-CART-007	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wugen, Inc.
• Investigators: Study Director: Jan Davidson-Moncada, MD, PhD, Wugen, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Estimated): July 1, 2037
• Study Completion (Estimated): July 1, 2037

Study Registration Dates

• First Submitted: July 20, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: T-ALL; T-LBL
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: WUC007-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No