11.2 Evaluation of TIL Cells Prior to Week-1 
11.2.1 Immediately after recovery of TIL cells from the CELLector™ 
Flasks 
Aerobic and anaerobic culture 
Gram stain 
11.2.2 Two days (48 hours) prior to the TIL infusion 
Aerobic and anaerobic culture 
Mycoplasma test 
Gram stain 
11.3 TIL Infusion Evaluation (Week- 1) 
Any adverse event that may be related to the TIL infusion will be 
recorded. The following evaluations will be performed and 
recorded: 
11.3.1 Clinical Evaluation (Day one of week- 11 
Weight 
Concomitant medications 
CBC with differential, platelet count 
Serum chemistry 
Urinalysis 
Coagulation profile (PT, PTT) 
EKG, chest x-ray, and CT or MRI brain 
scan, as clinically indicated 
11.3.2 Laboratory Evaluation of TIL Cells (Prior to or concurrently with TIL 
infusion on day one of week- 1 1 
Cell yield, log expansion, cell viability 
Phenotype 
Panel (FITC/PEL 
Isotype/Isotype, CD3/CD8, CD3/CD4, CD3/CD56 
CD16/CD56, CD8/CD38, CD8/Leu8, CD8/CD25 
CD8/CDllb, CD8/Anti HLA-DR, CD8/CD45RA 
CD8/CD29, CD3/TCR 
Cytotoxicity 
(K562, Daudi, Allogenic and Autologous Tumor) 
Prior to infusion of TIL cells a Gram stain is performed and an 
aliquot is obtained for confirmatory aerobic and anaerobic culturing 
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