Advanced Biliary Tract Cancer Clinical Trial
Official title:
Phase 1 Clinical Trial to Evaluate the Safety of Allogeneic NK Cell ("SMT-NK") Cell Therapy in Advanced Biliary Tract Cancer
Verified date | January 2019 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 9 |
Est. completion date | September 27, 2018 |
Est. primary completion date | September 27, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - patients with pathologically proven biliary tract cancer (gallbladder cancer, cholangiocarcinoma), - patients with refractory disease after chemotherapy and/or patients who have difficulty with chemotherapy due to side effects of chemotherapy - 18y=age=75y - ECOG performance status (ECOG-PS) =2 - Patients who meet the following conditions; 1)ANC = 1,500/µL, 2) Hemoglobin) = 10 g/dL, 3) PLT > 100,000/ µL, 4) Serum BUN & Creatinine = 1.5 x ULN, 5) AST & ALT = 2.5 x ULN, 6) Bilirubin = 3mg/L - Informed consent Exclusion Criteria: - Immune deficiency or autoimmune disease that can be exacerbated by immunotherapy - Pregnancy - Patients who have a history of other malignancies except skin cancer, local prostate cancer or cervical intraepithelial neoplasm within 5 years before the start of this study - Serious allergic history, psychological disease - Breast feeding or Patients planning pregnancy |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose limiting toxicity | Adverse event and drug related toxicity will be checked every week by the investigator's monitoring. | 1 week after NK cell injection | |
Primary | Dose limiting toxicity | Adverse event and drug related toxicity will be checked every week by the investigator's monitoring. | 2 weeks after NK cell injection | |
Primary | Dose limiting toxicity | Adverse event and drug related toxicity will be checked every week by the investigator's monitoring. | 3 weeks after NK cell injection | |
Primary | Dose limiting toxicity | Adverse event and drug related toxicity will be checked every week by the investigator's monitoring. | 4 weeks after NK cell injection | |
Primary | Maximum Tolerated Dose | Adverse event and drug related toxicity will be checked every week by the investigator's monitoring. | 1 week after NK cell injection | |
Primary | Maximum Tolerated Dose | Adverse event and drug related toxicity will be checked every week by the investigator's monitoring. | 2 weeks after NK cell injection | |
Primary | Maximum Tolerated Dose | Adverse event and drug related toxicity will be checked every week by the investigator's monitoring. | 3 weeks after NK cell injection | |
Primary | Maximum Tolerated Dose | Adverse event and drug related toxicity will be checked every week by the investigator's monitoring. | 4 weeks after NK cell injection |
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