By InvitationNot Applicable

A Long-Term Safety Follow-Up Study for Patients Treat With WU-CART-007

United States, Australia44 participantsStarted 2022-08-22

Plain-language summary

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.

Who can participate

Age range12 Years

SexALL

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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

What they're measuring

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

Timeframe: up to 15 years

Persistence of WU-CART-007 cells

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

Tanner Staging

Timeframe: up to 15 years

Trial details

NCT IDNCT05509855

SponsorWugen, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2037-07-01

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