7.3 Autologous CD8( + ) and CD4(+) Lymphocytes 
Both CD8(+) and CD4(+) T-cells will be selected from the tumor deposits using 
the AIS CELLector™ CD8 or CD4 Cell Culture Flask. CD8 or CD4 murine 
monoclonal antibodies are covalently bound to the surface of the Flask. The 
selected T-cells will be expanded in the presence of rIL-2. A dosage of 10 9 to 
10 11 cells in 5 percent normal human serum albumin will be infused into the 
patient of origin. 
8. DEVICE DESCRIPTION 
8.1 AIS CELLector™ CD8 and CD4 Cell Culture Flasks consist of a polystyrene 
tissue culture flask with murine CD8 or CD4 monoclonal antibodies covalently 
bonded to he polystyrene surface of the flask. The adherence of the antibodies 
to the flask surface remains stable throughout the cell separation procedure. The 
CELLector™ CD8 Cell Culture Flask selects CD8(+) T-cells from peripheral 
mononuclear cells (PMBC) or cultured lymphocytes. The CELLector™ CD8 Cell 
Culture Flask yields a 95 percent pure and viable CD8(+) cell preparation. The 
flask is terminally sterilized, therefore, CD8 cell separation occurs within a 
protective and sterile environment. 
9. ADMINISTRATION AND DOSAGE 
The infused CD8(+) and/or CD4(+) TIL cells will be supported by a four week 
course of therapy consisting of a continuous infusion of 2 x 10 6 BRMP units of 
rIL-2 every 24 hours for 4 days via a continuous intravenous infusion pump. 
Renal cell carcinoma patients will also receive IFNaA either by intramuscular or 
subcutaneous injection on days one and 4 of each week. Additional four week 
courses of therapy of rIL-2 and IFNorA may be given if clinically indicated. 
Therapy in this protocol is designed to be administered on an outpatient basis. 
9.1 Administration of rIL-2 
The Parker Micropump Model 2004 will be used to administer rIL-2 continuously 
for 4 days during each week of the four week course of therapy Patients or the 
responsible individual will receive instructions for use of the Parker Micropump 
and will also be informed of the Guidelines for Outpatient Administration pf rIL-2 
and IFNaA (Appendix VII). Outpatient administration will depend on each 
patient’s tolerance of the therapy and the judgement of the investigator. 
Eligible patients will receive at least one course of therapy, where each course 
consists of four consecutive weeks of rIL-2, 2x10* U/m 2 /day, continuous infusion 
(CIV) on days one through 4 of each week. The rIL-2 infusion will begin one to 
Recombinant DNA Research, Volume 15 
[527] 
