Table 1.

Objectives and endpoints of the TREAT-ME1 study

Objective	Endpoint
Primary	Safety and tolerability of MSC_apceth_101 (phase I and II)
Key secondary	• Total and individual size of relapse/metastases by CT or MRT according to RECIST criteria (phase I/II, group 1)
	• Detection of the therapeutic transgene expressed by homing MSC in resected tumor specimen by PCR technique shortly after its administration (phase II, group 2)
	• For comparison: Detection of the therapeutic transgene expressed by homing MSC in normal tissue adjacent to the tumor (phase II, group 2)
	• Optionally: PET activity in initially PET positive patients (phase I/II, group 1)
	•Tumor/serum markers (phase I/II, both patient groups)
Other secondary	•Time to progression up to 1 year after first MSC_apceth_101 administration (phase I/II)
	• Overall survival up to 1 year after first MSC_apceth_101 administration (phase I/II)