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.
Study Type
OBSERVATIONAL
Enrollment
150
No intervention
Stanford University
Stanford, California, United States
RECRUITINGYale University
New Haven, Connecticut, United States
RECRUITINGUniversity of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
The incidence of serious and non serious adverse events of special interest
AESIs will be collected
Time frame: Up to 15 years
Number of subjects with measurable replication competent lentivirus in peripheral blood (if positive at study entry)
Peripheral blood samples may be collected for RCL assessment
Time frame: Up to 15 years
Duration of zamtocabtagene autoleucel persistence
Peripheral blood samples will be collected to test for CAR T cells
Time frame: Up to 5 years
Objective response rate
ORR
Time frame: Up to 15 years
Overall Survival
OS
Time frame: Up to 15 years
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGFroedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
RECRUITING