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

NCT05509855 | Enrolling By Invitation FDA Drug

• 1 other identifier: WUC007-02
• Study Type: observational
• Target: 44
• Locations: 2 countries
• Sites: 5

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.

Conditions

T-cell Acute Lymphoblastic Leukemia; T-cell Lymphoblastic Lymphoma

Keywords

T-ALL; T-LBL

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Overall survival (OS)

  up to 15 years

• Progression-free survival (PFS)

  up to 15 years

Study Arms (1)

Patients treated with WU-CART-007

Patients who received previous treatment with WU-CART-007

Genetic: Genetic: WU-CART-007

Interventions

Genetic: WU-CART-007 GENETIC

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

Patients treated with WU-CART-007

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• Wugen, Inc.: lead

Study Sites (5)

City of Hope

Duarte, California, 91010, United States

Location

Childrens Hospital LA

Los Angeles, California, 90027, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Peter MacCullam Cancer Center

Melbourne, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Test for replication-competent lentivirus (RCL) and cellular persistence following treatment with WU-CART-007 will be performed until cells are undetectable.

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Cherry Thomas, MD

  Wugen, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: August 22, 2022
• Study Start: August 22, 2022
• Primary Completion (Estimated): July 1, 2037
• Study Completion (Estimated): July 1, 2037
• Last Updated: November 20, 2024

Record last verified: 2024-09

Locations

US (4); AU (1)