Long-term Follow-up of Subjects Exposed to Lentiviral-based CART-EGFRvIII Gene-modified Cellular Therapy Products in Cancer Studies
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This is a non-therapeutic, long-term follow-up (LTFU) study of subjects who have received retroviral-based gene therapy products in cancer studies. All subjects in this LTFU protocol have received lentiviral modified T cells engineered to express an anti-EGFRvIII scFv Chimeric Antigen Receptor (CAR).
Condition or disease
Subjects Entering Into This Protocol Will be Followed for up to 15 Years After Initial CART-EGFRvIII Infusion
The primary objective of this study is to monitor adult subjects, who as participants of a clinical trial, received T cells modified by a lentiviral vector encoding a chimeric antigen receptor specific for EGFRvIII, for adverse events that may be associated with lentiviral vector gene transfer such as insertional oncogenesis.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects who have participated in a lentiviral vector study and have received CART-EGFRvIII cells.
Subjects will be enrolled into this destination protocol because they have received CART-EGFRvIII cells that were genetically modified with a lentiviral vector. All subjects who have participated in a lentiviral vector study under IND 15968 and have received CART-EGFRvIII cells will be asked to participate in this protocol.
Subjects 18 years of age and older
Subjects who have provided informed consent prior to their study participation.