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A Prospective, Observational, Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a United States Miltenyi Biomedicine-Sponsored Clinical Study
This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.
This is a non-therapeutic study design. After successful screening, subjects will be monitored for potential gene therapy-related adverse events for up to 15 years post MB-CART2019.1 infusion. Subjects will be assessed yearly for the occurrence of delayed adverse events (AEs), monitored for replication competent lentivirus (RCL) and assessed for long term efficacy as well as CAR-T persistence.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Stanford University
Stanford, California, United States
Yale University
New Haven, Connecticut, United States
University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Start Date
May 15, 2024
Primary Completion Date
December 1, 2039
Completion Date
December 1, 2039
Last Updated
November 20, 2024
150
ESTIMATED participants
Long-term Follow-Up
OTHER
Lead Sponsor
Miltenyi Biomedicine GmbH
NCT05529069
NCT05442515
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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