A Prospective, Observational, Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a United States Miltenyi Biomedicine-Sponsored Clinical Study
- Study HIC#:2000036664
- Last Updated:11/22/2024
This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.
Contact Us
For more information about this study, including how to volunteer, contact:
Iris Isufi
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Trial Purpose and 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 Criteria
Inclusion Criteria:
- Received zamtocabtagene autoleucel in a Miltenyi Biomedicine-sponsored clinical study and have either completed the study or have discontinued early from the study.
- Provided written informed consent to participate in this study.
Exclusion Criteria:
- None
