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 — 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

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-007
    Patients 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)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Childrens Hospital LALos AngelesCalifornia90027-
Washington UniversitySt LouisMissouri63110-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-

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