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

First listed
Aug 22, 2022
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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