MesoPher/Mitazalimab-combination Therapy in Metastatic Pancreatic Disease (REACtiVe-2 Trial)
Summary
Pancreatic cancer is expected to be the second leading cause of cancer-related death in 2020. Pancreatic cancer is known as an immunological cold tumor. It is thought that the characteristic desmoplastic stroma of established pancreatic adenocarcinomas acts as a physical as well as an immunosuppressive barrier leading to exclusion of T cells. The use of CD40 agonists (such as mitazalimab, also known as JNJ-64457107 and ADC-1013) may convert pancreatic adenocarcinomas into immunological hot tumors by T-cell-dependent and T-cell-independent mechanisms. Targeting the desmoplastic stroma, thereby making the tumor more permeable for T-cell infiltration, is seen as one of the assisting mechanisms. Furthermore, the immunological coldness of pancreatic cancers infers that tumor-reactive T-cell responses are absent or weak at best. Dendritic cell therapy introduces tumor-specific T cells and in combination with a CD40 agonist, may lead to synergistic anti-tumor responses which could be beneficial for pancreatic cancer patients.
Timeline
- Start
- 2021-08-30
- Primary completion
- 2023-05-23
- Completion
- 2023-05-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MesoPher | Cell therapy | 25 cells | Intravenous |
| Subject | Mitazalimab | Monoclonal antibody | 75 ug/kg | Intravenous |
| Subject | Mitazalimab | Monoclonal antibody | 150 ug/kg | Intravenous |
| Subject | Mitazalimab | Monoclonal antibody | 300 ug/kg | Intravenous |
| Subject | Mitazalimab | Monoclonal antibody | 600 ug/kg | Intravenous |
| Subject | Mitazalimab | Monoclonal antibody | 1200 ug/kg | Intravenous |