Consultation visit | 1 | 2, 6, 10 | 3, 7, 11 | 4, 8, 12 | 5, 9, 13 | 14 | 15 | 16 | 17 | 18 |
---|---|---|---|---|---|---|---|---|---|---|
Days | (−10) to (−3) | 1/8/15 | 3/10/17 | 4/11/18 | 5/12/19 | 29±3 | 56±7 | 168±14 | 252±14 | 336±14 |
Parameter | Screening 1 | MSC_apceth_101 infusion 2 | GCV infusions 3 | |||||||
Informed consent | X | |||||||||
Inclusion/exclusion criteria | X | |||||||||
Medical history/demography | X | |||||||||
Physical examination | X | |||||||||
Adverse events | X | X | X | X | X | X | ||||
Concomitant medication | X | X | X | X | X | X | X | |||
Vital signs | X | X4 | X5 | X6 | X | X | X | |||
Body weight | X | X7 | X | X | ||||||
12-lead ECG | X | X | X | |||||||
Cardiac monitoring | X8 | X9 | X10 | |||||||
Oxygen saturation | X8 | X9 | X10 | X | ||||||
Tumor markers 11 | X | X | ||||||||
Tumor status | X | X | ||||||||
MSC_apceth infusion | X | |||||||||
GCV infusion | X12 | X | X | |||||||
MRT or CT (PET optional) | X13 | X14 | ||||||||
QoL assessment | X | X | X | |||||||
Serum pregnancy test | X | X | ||||||||
Urine analysis | X | X | ||||||||
Hematology | X | X | X | X | X | |||||
Blood chemistry | X | X | X | X | X | X | X | |||
Creatinine clearance | X | |||||||||
Inflammation markers | X | X | X | |||||||
Coagulation markers | X | X | X | X | X | |||||
Infectious disease markers | X | X | ||||||||
Lymphocyte subsets | X | X | X | |||||||
Biomarker samples | X | X | X10 | |||||||
Retention samples | X7 | X | X | |||||||
Immunogenicity samples | X | X | ||||||||
ECOG | X | X | ||||||||
Disease status 15 | X | X | X |