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RNA Transfected Dendritic Cell Vaccines: Preclinical and Clinical Results
Dendritic cells (DC) generated from peripheral blood monocytic cells (PBMC) of prostate cancer patients and transfected with PSA-RNA are remarkably effective in stimulating potent T cell mediated anti-tumor immunity in vitro. We have performed a phase I clinical trial designed to evaluate the safety and bioactivity of the DC vaccine in 14 patients with metastatic, hormone-refractory prostate cancer. The demonstration of successful CTL generation in prostate cancer patients associated with significant impact on surrogate clinical endpoints in some patients provides a scientific rationale for further trials administering PSA RNA transfected DC vaccines in a minimal residual disease setting. The clinical and immunological experience from these trials is discussed, including the following:

    • Outcomes when dendritic cells were generated under clinical conditions from leukapheresis derived PBMC and were transfected with "naked" PSA RNA
    • Evaluations of patients who received 3 vaccinations through an iv/id route and were evaluated for toxicity as well as for immunological and clinical responses
    • Bioactivity levels of the vaccine when induction of primary, PSA specific CD8+ T cell responses were consistently measured from peripheral blood of all patients enrolled among all dose levels
    • Vaccination was further associated with a significant decrease of the serum PSA slope profiles (in 5 of 7 evaluable patients) as well as with rapid clearance of circulating tumor cells from peripheral blood in some of the immunological responders

Johannes Vieweg, MD
Assistant Professor of Urology and Immunology