Expanded Access Study for the Treatment of Patients with Commercially Out-of-Specification Brexucabtagene Autoleucel
Categories (click each to see list of all clinical trials associated with that category): Cellular Therapy Support Service - CAR-T (ONC), Leukemia/MDS/MPD (ONC), Lymphoma/CLL (ONC)
Current Status: Open
Phase: N/A
Principal Investigator: Lunning, Matthew
Contact Information:
Sarah Snook
sarah.snook@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT05776134?term=NCT05776134&draw=2&rank=1#eligibility
Summary
The objective of this study is to provide access to brexucabtagene autoleucel that is OOS for commercial release to subjects with a relevant FDA approved labeled indication.
The outcome measure is:
Incidence of SAEs and deaths from informed consent to 30 days post infusion or early withdrawal