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

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 1^st GCV infusion and including the 3^rd 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 1^st GCV infusion and before and 15, 30, 60 min and 2 h after 2^nd GCV infusion; ⁷ Before and 15, 30, 60 min, 2 h after the start of each GCV infusion; ⁸ before MSC infusion; ⁹ before 1^st 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 1^st GCV infusion; ¹² 1.5 h (±0.5 h) after start of 3^rd 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.

ISSN: 1471-2407