drugset / Trial / NCT04203901

Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma

NCT04203901

Phase 2 Terminated 16 enrolled CoImmune
RandomizedParallel-groupOpen-labelTreatment

Summary

CMN-001 is an autologous, tumor antigen-loaded dendritic cell immunotherapy. The active components of CMN-001 are autologous, matured dendritic cells, which have been co-electroporated with both in vitro transcribed (IVT) RNA from an autologous tumor specimen and CD40L RNA. CMN-001 is indicated for treatment of intermediate/poor risk patients with advanced renal cell carcinoma (RCC) in combination with nivolumab plus ipilimumab as first line therapy and in combination with lenvatinib plus everolimus as 2nd line therapy post 1st line failure.

Timeline

Start
2020-07-22
Primary completion
2023-09-28
Completion
2023-09-28

Drugs

EvaluationDrugModalityDoseRoute
Subject CMN-001 Cell therapy 1e+07 cells
Background Everolimus Small molecule 5 mg
Background Ipilimumab Monoclonal antibody 1 mg/kg
Background Lenvatinib Small molecule 18 mg
Background Nivolumab Monoclonal antibody 3 mg/kg

Indications