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Rocapuldencel-T (AGS-003) is an autologous dendritic cell-based immunotherapy developed by Argos Therapeutics for the treatment of metastatic renal cell carcinoma (mRCC). The therapy is fully personalized, manufactured using a patient's own monocyte-derived dendritic cells which are co-electroporated with amplified tumor RNA (derived from the patient's own tumor tissue) and synthetic CD40 ligand (CD40L) RNA. This process is designed to mature the dendritic cells and prime them to trigger a robust T-cell mediated immune response against a broad spectrum of both mutated and non-mutated tumor-specific antigens. While early-phase trials showed promise, the pivotal Phase 3 ADAPT trial, which combined rocapuldencel-T with sunitinib, was terminated in 2017 after an interim analysis concluded the study was unlikely to meet its primary endpoint of improving overall survival.
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