A Long-Term Safety Follow-Up Study for Patients Treat With WU-CART-007
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Delayed adverse events (AEs)/serious adverse events (SAEs) [up to 15 years]
assess the risk of delayed adverse events including serious events following exposure to WU-CART-007
- Persistence of WU-CART-007 cells [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
- Tanner Staging [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 Outcome Measures
- Overall survival (OS) [up to 15 years]
To evaluate survival n patients previously treated with WU-CART-007
- Progression-free survival (PFS) [up to 15 years]
To evaluate profession free survival in patients previously treated with WU-CART-007
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Wugen, Inc.
Investigators
- Study Director: Ken Jacobs, MD, Wugen, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WUC007-02