Clinical Study of Chimeric EGFR Antigen Receptor-modified T Cells in Chemotherapy Refractory Advanced Solid Tumors
I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced
with the anti-EGFR vector (referred to as CART-EGFR cells).
II. Determine duration of in vivo survival of CART-EGFR cells. RT-PCR (reverse transcription
polymerase chain reaction) analysis of whole blood will be used to detect and quantify
survival of CART-EGFR TCR zeta:CD137 and TCR (T-cell receptor) zeta cells over time.
I. For patients with detectable disease, measure anti-tumor response due to CART-EGFR cell
II. Estimate relative trafficking of CART-EGFR cells in tumor bed.
III. Determine if cellular or humoral host immunity develops against the murine anti-EGFR,
and assess correlation with loss of detectable CART-EGFR (loss of engraftment).
IV. Determine the relative subsets of CART-EGFR T cells (Tcm, Tem, and Treg).
OUTLINE: Patients are assigned to 1 group according to order of enrollment.
Patients receive anti-EGFR-CAR (coupled with CD137 and CD3 zeta signalling
domains)vector-transduced autologous T cells on days 0,1, and 2 in the absence of
After completion of study treatment, patients are followed intensively for 6 months, every 3
months for 2 years, and annually thereafter for 13 years.
Estimate relative trafficking of CART-EGFR cells in peripheral blood.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Occurrence of study related adverse events
Until week 24
weidong han, Dr.
Chinese PLA General Hospital
China: Ethics Committee