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**BJ-001 + pembrolizumab** is an investigational combination therapy for cancer consisting of BJ-001 (a tumor-targeting IL-15 fusion protein) and pembrolizumab (a monoclonal antibody targeting the PD-1 receptor). BJ-001 is designed to stimulate anti-tumor immune responses via the IL-15/IL-15 receptor pathway, promoting proliferation and activation of natural killer (NK) and CD8+ T cells. Pembrolizumab is an anti-PD-1 immune checkpoint inhibitor, blocking the interaction between PD-1 and its ligands (PD-L1/PD-L2), thereby enhancing T-cell mediated antitumor activity. The combination aims to overcome resistance to immune checkpoint blockade by enhancing and sustaining anti-tumor immune responses. It is being evaluated primarily in patients with locally advanced or metastatic solid tumors, including those previously treated with checkpoint inhibitors. Early-phase trials are focused on safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity[1][3][5][7].
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