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) |