Natural killer (NK) cells play a central role within the innate immune system and are able to recognize abnormal cells without prior sensitization. In recent years, NK cell–based immunotherapy has gained significant attention, with multiple clinical studies reporting new data that support ongoing research and development efforts.
Progress of the SMT-NK Program
SMTBio in Korea is developing an allogeneic NK-cell therapeutic product, SMT-NK. The therapy is currently under evaluation in a Phase 2b/3 clinical trial for cholangiocarcinoma. According to publicly available information, the trial is progressing as scheduled and is expected to complete its key assessment stage in 2026.
A 2024 industry report by KuickResearch indicates that SMT-NK may have the potential to move toward regulatory submission in the future, depending on the results of ongoing and upcoming clinical studies.
Clinical Data in Chemotherapy-Refractory Cholangiocarcinoma
The journal Cancers published results from a Phase 1/2a study evaluating SMT-NK in combination with pembrolizumab in patients with chemotherapy-refractory advanced cholangiocarcinoma. Key findings included:
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Overall response rate (ORR): 17.4% in the full analysis set
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ORR in patients who completed study procedures per protocol: 50.0%
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Disease control rate (DCR): 73.9%
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Median progression-free survival (PFS): 4.1 months (95% CI: 1.8–5.9)
The study also reported cases in which patients previously unresponsive to chemotherapy achieved measurable reductions in tumor burden after receiving the combination regimen. These results support continued clinical evaluation in larger populations.
Immunological Features of NK Cells
NK cells contribute to antitumor immunity through multiple mechanisms, including:
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Release of cytotoxic granules such as perforin and granzymes
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Activation of death-receptor pathways
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Secretion of cytokines to modulate the tumor microenvironment
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Antibody-dependent cellular cytotoxicity (ADCC)
These biological characteristics position NK cells as an important focus of cell-based immunotherapy development.
Clinical Exploration Across Tumor Types
Research efforts in other tumor types have also reported preliminary findings:
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Signet Ring Cell Gastric Cancer
A case report in Medicine (Baltimore) described a patient who remained free of recurrence during long-term follow-up after receiving NK-cell infusions in addition to surgery and chemotherapy.
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Locally Advanced Colon Cancer
A study published in Cytotherapy suggested that combining NK-cell therapy with chemotherapy may help extend progression-free survival in selected patients, supporting further investigation in adjuvant treatment settings.
Outlook
As NK-cell therapy continues to advance, upcoming large-scale studies will be essential to further evaluate its safety, efficacy, and potential roles across different stages and tumor types. Continued clinical evidence will also help refine patient selection and treatment strategies in the future.
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