A Long-Term Safety Follow-Up Study for Patients Treat With WU-CART-007
Part of paid clinical trials in Duarte, California.
- Sponsor
- Wugen, Inc.
- Study ID
- NCT05509855
- Status
- Enrolling By Invitation
Conditions
- T-cell Acute Lymphoblastic Leukemia
- T-cell Lymphoblastic Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Genetic: WU-CART-007 — GENETICNo 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
Study Details
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.
Key Dates
- Start date
- Aug 22, 2022
- Status verified
- Sep 2024
- Primary completion
- Jul 1, 2037
- Completion
- Jul 1, 2037
Study Design
- Enrollment
- 44 participants (estimated)
Arms
- Arm: Patients treated with WU-CART-007Patients who received previous treatment with WU-CART-007
Primary Outcome Measure
Delayed adverse events (AEs)/serious adverse events (SAEs) [ Time Frame: up to 15 years ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | - |
| Childrens Hospital LA | Los Angeles | California | 90027 | - |
| Washington University | St Louis | Missouri | 63110 | - |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | - |
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