Long-term Follow-up of Subjects Exposed to Lentiviral-based CART-EGFRvIII Gene-modified Cellular Therapy Products in Cancer Studies

University of Pennsylvania

Status: Completed

Conditions: Subjects Entering Into This Protocol Will be Followed for up to 15 Years After Initial CART-EGFRvIII Infusion

Study type: Observational

Funder types: Other

Identifiers

NCT02666248

UPCC 11315, 823264

Details and patient eligibility

About

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).

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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