drugset / Trial / NCT05650918

MesoPher/Mitazalimab-combination Therapy in Metastatic Pancreatic Disease (REACtiVe-2 Trial)

NCT05650918

Phase 1 Completed 22 enrolled Joachim Aerts, MD PhD
NaSequentialOpen-labelOther

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

EvaluationDrugModalityDoseRoute
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