Phase 1 Clinical Trial to Evaluate the Safety of Allogeneic NK Cell ("SMT-NK") Cell Therapy in Advanced Biliary Tract Cancer
Condition: Advanced Biliary Tract Cancer
MeSH terms: Biliary Tract Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Cholangiocarcinoma refers to bile duct cancer (bile duct cancer) and gallbladder cancer that
      develop in the gallbladder. According to the data from National Cancer Information Center in
      2013, the incidence of cancer in Korea is 5,283, which corresponds to about 2.3% of all
      cancers and the 5-year survival rate is 30% And most of the long-term survival is due to
      early detection by screening, and advanced carcinoma is a refractory carcinoma with a 5-year
      survival rate of less than 5%. In addition to the standard anticancer drugs, alternative
      anticancer drugs and targeted therapies have been developed to provide a variety of treatment
      modalities. However, the development of cell therapy drugs for cancer, such as cancers, has
      not been developed in Korea. .

      Natural killer cells (NK cells) are innate lymphocyte cells with cytotoxic activity. Unlike T
      cells and B cells, which have antigen-specific receptors, NK cells express various innate
      immunoreceptors on the cell surface, thereby enabling selective recognition of cancer cells
      And recognizes cancer cells, it is a cytotoxic cell that can immediately remove cancer cells
      without any other activation process. In addition, natural killer cells also interact with
      dendritic cells or T cells directly or indirectly to regulate the immune response, thereby
      inhibiting the development and metastasis of cancer cells and effectively removing cancer
      stem cells important for cancer recurrence It has many advantages in the development of
      anti-cancer immunotherapy.
    

Detailed description: 
      Cholangiocarcinoma refers to bile duct cancer (bile duct cancer) and gallbladder cancer that
      develop in the gallbladder. According to the data from National Cancer Information Center in
      2013, the incidence of cancer in Korea is 5,283, which corresponds to about 2.3% of all
      cancers and the 5-year survival rate is 30% And most of the long-term survival is due to
      early detection by screening, and advanced carcinoma is a refractory carcinoma with a 5-year
      survival rate of less than 5%. In addition to the standard anticancer drugs, alternative
      anticancer drugs and targeted therapies have been developed to provide a variety of treatment
      modalities. However, the development of cell therapy drugs for cancer, such as cancers, has
      not been developed in Korea. .

      Although surgical resection is mandatory for curettage of the biliary tract, 40 ~ 50% of all
      patients are able to undergo radical resection. In general, the incidence of mid / lower bile
      duct cancer is high and the upper bile duct cancer is relatively low. The surgical resection
      of the tumor depends on the location of the tumor. The curative surgery of the biliary cancer
      is very complicated and time-consuming. The anatomical structures of the biliary and vascular
      system are variable and it is difficult to accurately determine the extent of the tumor
      invasion before surgery or even during surgery there is also a great deal of risk. Especially
      in the case of hepatic portal biliary duct (upper bile duct cancer), it is difficult to judge
      whether surgical resection is feasible, and there are many cases where resection is difficult
      at the time of operation or discovery. Gallbladder cancer also has a poor prognosis. Early
      cancer can be cured by surgery, but progressive cancer has a poor prognosis and overall
      survival rate is similar to that of biliary cancer. Because it occurs in the biliary tract
      with bile duct cancer, the clinical method and characteristics of the cancer cells are
      similar, and the same method is used for the treatment and the chemotherapy.

      However, since there is no standard for the selection of second-line chemotherapy after
      gemcitabine treatment, the development of an alternative therapeutic agent is urgently
      required have.

      Natural killer cells (NK cells) are innate lymphocyte cells with cytotoxic activity. Unlike T
      cells and B cells, which have antigen-specific receptors, NK cells express various innate
      immunoreceptors on the cell surface, thereby enabling selective recognition of cancer cells
      And recognizes cancer cells, it is a cytotoxic cell that can immediately remove cancer cells
      without any other activation process. In addition, natural killer cells also interact with
      dendritic cells or T cells directly or indirectly to regulate the immune response, thereby
      inhibiting the development and metastasis of cancer cells and effectively removing cancer
      stem cells important for cancer recurrence It has many advantages in the development of
      anti-cancer immunotherapy.

      Therefore, various clinical studies have been conducted to treat cancer using natural killer
      cells worldwide, including in Korea, and therapeutic clinical results are shown for various
      cancers. The clinical application of natural killer cells is carried out by culturing natural
      killer cells isolated from blood of patient, patient's family or even from other people's
      blood and injecting them into patients. It is also possible to expect the effect as a
      combination therapy with chemotherapy alone or by eliminating the cancer cells in the
      patient's body while improving the immunity of the patient by improving the immunity of the
      patient.

      However, despite this, the clinical application of natural killer cells in Korea is limited
      to only a few cancers, including hematologic and hepatocellular carcinoma.

      Carcinoid cancer (biliary cancer, gallbladder cancer) is a rare carcinoma with around 3,500
      cases per year in Korea. In the majority of cases, the rate of relying entirely on
      chemotherapy is more than 50%, and the response rate of Gemcitabine based on the first
      chemotherapy is about 30%. Other alternative therapies that do not lead to cancer are natural
      killer cells that need to be tested for safety and efficacy in existing drugs.

      In Korea, the clinical application of natural killer cells is limited to only a few cancers,
      including hematologic and hepatocellular carcinomas. Carcinoid cancer (biliary cancer,
      gallbladder cancer) is a rare carcinoma with around 3,500 cases per year in Korea. In the
      majority of cases, the rate of relying entirely on chemotherapy is more than 50%, and the
      response rate of Gemcitabine based on the first chemotherapy is about 30%. Other alternative
      therapies that do not lead to cancer are natural killer cells that need to be tested for
      safety and efficacy in existing drugs.
    

Intervention name(s): Natural killer cell
Intervention type(s): Biological
Intervention description(s): Patients who received natural killer cell injection
Other intervention name(s): SMT-NK cell
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment