The majority of the anticipated adverse reactions in patients enrolled in studies involving 
autologous cell expansion and infusion are most often related to the rIL-2 therapy. The 
literature clearly describes adverse events associated with higher ( > 10 6 BRMP units) dose 
rIL-2 therapy which resolve upon cessation of the rIL-2. There is a risk that the therapy 
will have no effect on the tumor size and the study subject will gain no benefit from the 
therapy. Conversely, elimination or significant reduction in the size of the tumor may 
result in a longer survival and even potential cure. 
5. CONDUCT OF STUDY 
5.1 Overall design 
This is an open, sequential phase I safety study of the concomitant administration of 
"genetically marked" TILs, TIL subsets and PBL and PBL subsets with IL-2 alone or in 
combination with IFNaA in patients with metastatic melanoma and renal cell carcinoma. 
The treatment components are outlined below. 
MELANOMA 
SUBGROUP 
A 
ms 
5 
CELLS 
bulk TIL 
bulk PBL 
VECTOR 
LNL6 
GIN 
BIOLOGICAL 
IL-2 
B 
5 
CD8( + )TIL 
CD8( + )PBL 
LNL6 
GIN 
IL-2 
C 
5 
CD4( + )TIL 
CD4( + )PBL 
LNL6 
GIN 
IL-2 
D 
5 
CD8( + )TIL 
CD4( + )TIL 
LNL6 
GIN 
IL-2 
[520] 
Recombinant DNA Research, Volume 15 
