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Table 3 Investigational schedule for patients in group 2 of phase 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 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
  1. 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.