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SM3321 is a novel dual-targeting nanobody-based immunotherapy designed as a CD16A (FCGR3A) agonist for cancer treatment. It is classified as a nano-multi-antibody and functions by engaging natural killer (NK) cells through the CD16A receptor to mediate anti-tumor activity. The drug is being developed primarily for the treatment of relapsed or refractory advanced malignancies, including solid tumors and hematological cancers such as acute myeloid leukemia and multiple myeloma. Its mechanism involves activating NK cells to enhance immune-mediated tumor cell killing. The developer of SM3321 is Beijing StarMab BioMed Technology (also referred to as Beijing Shuoxing Biomedical Technology). As of late 2023/early 2024, it has entered Phase I clinical trials in patients with locally advanced or metastatic solid tumors in China, with additional preclinical development ongoing for hematologic malignancies[1][2][3][4].
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