This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.
Received zamtocabtagene autoleucel in a North American Miltenyi Biomedicine-sponsored clinical study and have not withdrawn consent to be followed or been deemed lost to follow-up.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.
None
Patients who have received MB-CART2019.1
Cohort
Prospective
Long-term Follow-Up
Other interventionNo intervention
Number of subjects with new or recurrence of pre-existing malignancy
Number of subjects with new incidence or exacerbation of a pre-existing neurological disorder
Number of subjects with new incidence or exacerbation of pre-existing rheumatologic or other autoimmune disorders
Number of subjects with new incidence of Grade ≥ 3 hematologic disorders
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
Duration of zamtocabtagene autoleucel persistence
Peripheral blood samples will be collected to test for CAR T cells
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
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
Click on the lead sponsor to view all of their trials.
