A Prospective, Observational, Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a North American Miltenyi Biomedicine-Sponsored Clinical Study
Miltenyi Biomedicine GmbH
Summary
This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Received zamtocabtagene autoleucel in a North American Miltenyi Biomedicine-sponsored clinical study and have not withdrawn consent to be followed or been deemed lost to follow-up. * Provided written informed consent to participate in this study. Exclusion Criteria: * None
Interventions
- OtherLong-term Follow-Up
No intervention
Locations (11)
- Banner MD Anderson Cancer CenterGilbert, Arizona
- Stanford UniversityStanford, California
- Yale UniversityNew Haven, Connecticut
- Robert H Lurie Cancer CenterChicago, Illinois
- University of Kansas Cancer CenterWestwood, Kansas
- University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer CenterBaltimore, Maryland