Subjects Entering Into This Protocol Will be Followed for up to 15 Years After Initial CART-EGFRvIII Infusion
Conditions
Brief summary
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).
Detailed description
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.
Interventions
None listed
Sponsors
University of Pennsylvania
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events | 15 years |
Countries
United States
Outcome results
None listed