drugset / Trial / NCT02692976

Natural Dendritic Cells for Immunotherapy of Chemo-naive Metastatic Castration-resistant Prostate Cancer Patients

NCT02692976 ↗

Phase 2 Completed 21 enrolled Radboud University Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

Prostate cancer is the only type of cancer in which conventional dendritic cells (DC) treatment has a beneficial effect on the overall survival. In this study investigators aim to show immunologic efficacy of tumor-peptide loaded natural DC in metastatic castration-resistant prostate cancer patients (mCRPC). The immunomonitoring will include: 1. functional response and tetramer analysis of delayed-type hypersensitivity infiltrating lymphocytes against tumor peptides and 2. type I interferon (IFN) gene expression in peripheral blood mononuclear cells, and 3. proliferative, effector cytokine- and humoral responses to keyhole limpet hemocyanin, a immunogenic protein providing T cell help. The secondary objectives are the safety and feasibility of natural DC vaccinations, the influence on the quality of life during treatment with natural DC, and the clinical efficacy of treatment.

Timeline

Start
2015-09
Primary completion
2017-09
Completion
2019-03-06

Drugs

EvaluationDrugModalityDoseRoute
Subject CD1c+ myeloid dendritic cells Cell therapy 5e+06 cells Other
Subject plasmacytoid DCs Cell therapy 3e+06 cells Other

Indications