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Table 2 Investigational schedule for patients in group 1 of phase I and II

From: Treatment of advanced gastrointestinal tumors with genetically modified autologous mesenchymal stromal cells (TREAT-ME1): study protocol of a phase I/II clinical trial

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
  1. Footnotes:1 not earlier than two weeks after end of chemo-/radiotherapy; 2 24 h (±2 h) inpatient monitoring after end of MSC_apceth_101 infusions;3 24 h (±3 h) inpatient monitoring after start of 1st GCV infusion and including the 3rd GCV infusion (discharge from hospital 2 h after 3rd infusion); 4 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; 5 Before and 15,30,60 min, 2 h, 4 h (±0.5 h), 6 h (±1 h), 8 h (±1 h) after start of 1st GCV infusion and before and 15, 30, 60 min and 2 h after 2nd GCV infusion;6 Before and 15, 30, 60 min and 2 h after each GCV infusion; 7 Before MSC_apceth_101 infusion; 8 Before and 6 h (±1 h) and 24 h (±2 h) after start of infusion of MSC_apceth_101; 9 Before and 6 h (±1 h) after start of first infusion of GCV; 10 1.5 h (±0.5 h) after 3rd GCV infusion; 11 tumor marker: CEA, CA15-3, CA19-9, CA125, CA72-4, Cyfra21-1, AFP; only tumor marker applying for the tumor entity are determined;12 First GCV infusion not earlier than 48 h after preceding MSC_apceth_101 infusion; 13 Scans not older than 4 weeks can be used as baseline scans;14 MRT or CT or PET whatever was used at visit 1; repeat PET only if PET was done at visit 1; MRT or CT or PET can be carried out up to 28 days after day 56 if this is more convenient for the procedures in the hospital. 15 Survival status, any new relapses/metastasis, ECOG, treatment history: chemotherapy, radiotherapy, any other antitumor treatment.