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Enrolling by Invitation

NCT Number: NCT05509855

A Long-Term Safety Follow-Up Study for Patients Treat With 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.

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peter MacCullam Cancer Center, Melbourne, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Delayed adverse events (AEs)/serious adverse events (SAEs)

    Time frame: up to 15 years

    assess the risk of delayed adverse events including serious events following exposure to WU-CART-007

  2. Persistence of WU-CART-007 cells

    Time frame: 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

  3. Tanner Staging

    Time frame: 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 outcomes

  1. Overall survival (OS)

    Time frame: up to 15 years

    To evaluate survival n patients previously treated with WU-CART-007

  2. Progression-free survival (PFS)

    Time frame: up to 15 years

    To evaluate profession free survival in patients previously treated with WU-CART-007

Sponsors and collaborators

Lead sponsor

Wugen, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2037
Study completion
2037
First posted
Aug 22, 2022
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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