Table 3.
Investigational schedule for patients in group 2 of phase II
| Consultation visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 111 | 12 | 13 | 14 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Days | (−10) to (−3) | 1 | 3 or 4 | 5 | 6 | 7 | 8 | 11 | 16±2 | 22±2 | 29±3 | 168±14 | 252±14 | 336±14 |
| Parameter | Screening2 | MSC infusion3 | Tumor resection | GCV infusions4 | ||||||||||
| Informed consent | X | |||||||||||||
| Inclusion/exclusion criteria | X | |||||||||||||
| Medical history/demography | X | |||||||||||||
| Physical examination | X | X | ||||||||||||
| Adverse events | X | X | X | X | X | X | X | X | X | X | ||||
| Concomitant medication | X | X | X | X | X | X | X | X | X | X | X | |||
| Vital signs | X | X5 | X6 | X7 | X7 | X | X | X | ||||||
| Body weight | X | X8 | X9 | X | X | X | ||||||||
| 12-lead ECG | X | X | X | |||||||||||
| Cardiac monitoring | X10 | X11 | X12 | |||||||||||
| Oxygen saturation | X13 | X11 | X12 | X | ||||||||||
| Tumor marker 14 | X | X | X | |||||||||||
| Tumor status | X | X | ||||||||||||
| MSC_apceth infusion | X | |||||||||||||
| Tumor resection 15 | X | |||||||||||||
| GCV infusion | X | X | X | |||||||||||
| Serum pregnancy test | X | X | ||||||||||||
| Urine analysis | X | X | X | |||||||||||
| Hematology | X | X | X | X | X | X | ||||||||
| Blood chemistry | X | X | X | X | X | X | ||||||||
| Creatinine clearance | X | |||||||||||||
| Inflammation markers | X | X | X | |||||||||||
| Coagulation markers | X | X | X9 | X | X | X | ||||||||
| Infectious disease markers | X | X | ||||||||||||
| Lymphocyte subsets | X | X | ||||||||||||
| Biomarker samples | X | X | ||||||||||||
| Retention samples | X8 | X | X | X | ||||||||||
| Immunogenicity samples | X | X | ||||||||||||
| ECOG | X | X | ||||||||||||
| Disease status | X | X | X |
Footnotes:1 in case subsequent chemo- or radiotherapy begins before day 29 all investigations of this day are to be carried out up to 5 days before therapy starts. Thereafter, no further AE recording is required; 2 not earlier than 2 weeks after end of chemo-/radiotherapy; 3 24 h (±2 h) inpatient monitoring after end of MSC infusion; 4 24 h (±3 h) inpatient monitoring after start of 1st GCV infusion and including the 3rd GCV infusion; 5 Before and 15, 30, 60 min, 2 h, 4 h (±0.5 h), 6 h (±1 h), 8 h (±1 h), 12 h (±3 h), and 24 h (±2 h) after the end of MSC_apceth_101 infusion; 6 Before and 15, 30, 60 min, 2 h, 4 h (±0.5 h), 6 h (±1 h), 8 h (±1 h), 12 h after start of 1st GCV infusion and before and 15, 30, 60 min and 2 h after 2nd GCV infusion; 7 Before and 15, 30, 60 min, 2 h after the start of each GCV infusion; 8 before MSC infusion; 9 before 1st GCV infusion; 10 Before and 6 h (±1 h) and 24 h (±2 h) after end of MSC infusion; 11 Before and 6 h (±1 h) after start of 1st GCV infusion; 12 1.5 h (±0.5 h) after start of 3rd GCV infusion; 13 Before and 6 h (±1 h) and 24 h (±2 h) after end of insufion of MSCs; 14 tumor marker: CEA, CA15-3, CA19-9, CA125, CA72-4, Cyfra21-1, AFP; only tumor marker applying for the tumor entity are determined; 15 Including biopsy of surrounding healthy tissue (will be used to detect MSCs) and should be at least 48 h after MSC infusion.