Clinical trial

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

Name

WUC007-02

Description

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.

Trial arms

Trial start

2022-08-22

Estimated PCD

2037-07-01

Trial end

2037-07-01

Treatment

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

Arms:

Patients treated with WU-CART-007

Size

Primary endpoint

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

up to 15 years

Persistence of WU-CART-007 cells

Every 6 months for up to 5 years and then yearly for up to 15 years

Tanner Staging

up to 15 years

Eligibility 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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Test for replication-competent lentivirus (RCL) and cellular persistence following treatment with WU-CART-007 will be performed until cells are undetectable.'}, 'enrollmentInfo': {'count': 44, 'type': 'ESTIMATED'}}

Updated at

2023-09-07

1 organization

1 product

2 indications

Organization

Wugen

Product

WU-CART-007

Indication

T-cell Acute Lymphoblastic Leukemia

Indication

T-cell Lymphoblastic Lymphoma