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
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
RECRUITINGStanford University
Stanford, California, United States
Number of subjects with new or recurrence of pre-existing malignancy
Time frame: Up to 15 years
Number of subjects with new incidence or exacerbation of a pre-existing neurological disorder
Time frame: Up to 15 years
Number of subjects with new incidence or exacerbation of pre-existing rheumatologic or other autoimmune disorders
Time frame: Up to 15 years
Number of subjects with new incidence of Grade ≥ 3 hematologic disorders
Time frame: Up to 15 years
Number of subjects with related AEs, related SAEs, and all AESIs
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 15 years
Objective Response Rate (ORR)
ORR for subjects who did not have progressive disease at their last assessment in the parent study; will be assessed by IRC and Investigator using Lugano 2014 Criteria for DLBCL and SCNSL and using IPCG Criteria (Abrey 2005) for PCNSL
Time frame: Up to 15 years
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Yale University
New Haven, Connecticut, United States
RECRUITINGRobert H Lurie Cancer Center
Chicago, Illinois, United States
RECRUITINGUniversity of Kansas Cancer Center
Westwood, Kansas, United States
RECRUITINGUniversity of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
NOT_YET_RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGDuke University Medical Center - Division of Hematologic Malignancies
Durham, North Carolina, United States
RECRUITINGOregon Health and Science University Knight Cancer Institute
Portland, Oregon, United States
RECRUITINGUT Southwestern Medical Center
Dallas, Texas, United States
RECRUITING...and 1 more locations
Overall Survival
OS, measured from the date of zamtocabtagene autoleucel infusion to the date of the subject's death or the date the subject is last to known to be alive
Time frame: Up to 15 years
To determine the number of subjects who relapse after zamtocabtagene autoleucel infusion during LTFU
Disease relapse: Number of subjects who enter the study as responders and relapse
Time frame: Up to 15 years
To assess immune reconstitution based on the recovery of total lymphocytes
Change from baseline in peripheral B cell and lymphocyte levels
Time frame: Up to 15 years