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ACT2001 is an autologous cell-based immunotherapy consisting of immature dendritic cells (DCs) developed by Alden Cancer Therapy II for the treatment of advanced malignancies, most notably metastatic castration-resistant prostate cancer (mCRPC). The therapy is utilized in a specialized "cryoimmunotherapy" protocol. This involves harvesting a patient's own monocytes via leukapheresis, differentiating them ex vivo into immature dendritic cells, and then injecting the resulting ACT2001 product directly into a tumor site immediately following cryoablation. The rationale is that cryoablation causes tumor cell lysis and the release of diverse tumor-associated antigens in situ, which the immature dendritic cells then capture and present to the immune system. This process is intended to mature the DCs and trigger a systemic, polyvalent T-cell-mediated anti-tumor response. In clinical trials, ACT2001 has been combined with low-dose metronomic cyclophosphamide and the checkpoint inhibitor ipilimumab to further enhance immune activation.
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