Long-Term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated with Gene-Modified Cells
Contact:
NCT Number:
Protocol:
AAAU1511
Study Status:
Active/Enrolling
Population:
Adult
Phase:
II
The purpose of this study is to monitor you for any delayed side effects that may possibly be related to the experimental gene-modified therapy product you received in the Kite-sponsored study for Axicabtagene ciloleucel (“axi-cel”). The main study does not involve treatment. In the re-treatment portion, you will be provided access to a second course of treatment with lymphodepleting chemotherapy and axi-cel. Axi-cel is manufactured using your own blood cells. If you meet the requirements for the retreatment part of this study, the study doctor will confirm if leftover product from your participation in the previous Kite-sponsored study can be used for your second dose.
Are you Eligible? (Inclusion Criteria)
- Have you received an infusion of gene-modified cells in a completed Kite- sponsored parent study?
- Are you able to understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-related assessments or procedures being conducted?
- Are you 18 years of age or older?
Specialty Area(s)
Blood and Marrow Stem Cell Transplantation, Immunotherapy
Principal Investigator
Trial Location(s)
CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032