T-cell Acute Lymphoblastic Leukemia Clinical Trial
Official title:
A Long-Term Safety Follow-Up Study for Patients Treated With Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007)
Verified date | September 2023 |
Source | Wugen, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 44 |
Est. completion date | July 1, 2037 |
Est. primary completion date | July 1, 2037 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Peter MacCullam Cancer Center | Melbourne | |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Washington University | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Wugen, Inc. |
United States, Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Overall survival (OS) | To evaluate survival n patients previously treated with WU-CART-007 | up to 15 years | |
Secondary | Progression-free survival (PFS) | To evaluate profession free survival in patients previously treated with WU-CART-007 | up to 15 years |
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