Ignite Creation Date:
2024-05-06 @ 1:05 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03937895
Status:
COMPLETED
Last Update Posted:
2022-03-29
First Post:
2019-04-29
Brief Title:
Allogeneic NK Cell SMT-NK in Combination With Pembrolizumab in Advanced Biliary Tract Cancer
Sponsor:
SMT bio Co Ltd
Organization:
SMT bio Co Ltd
Study Overview
Official Title:
Phase 12a Clinical Trial for the Evaluation of Safety and Efficacy of Allogeneic NK Cell SMT-NK in Combination With Pembrolizumab for Patients With Gemcitabine-refractory Biliary Tract Cancer
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The term of biliary tract cancer BTC or cholangiocarcinoma refers to all tumors that arise from the biliary tract or the biliary drainage system including the gallbladder According to the data from National Cancer Information Center in 2016 annual incidence of the cancer in Korea is 6685 131 per 100000 population which corresponds to about 29 of all cancers
BTC is one of the most prognostic cancer with less than 30 of 5-year survival rate and the case with long-term survival can be possibly done with early detection of the cancer However most of BTC is found in advanced stages due to the difficulty of early detection resulting in that the 5-year survival rate of the advanced BTC becomes less than 3 More than 50 of the patients depends on Gemcitabine based chemotherapy but response rate of the chemotherapy remains around 30 Thus improving the survival rate with the standard chemotherapy is very limited and furthermore selection of second-line therapy is not easy For this reason development of an alternative therapeutic agent is urgently required
NK natural killer cells are important cytotoxic innate immune cells that are involved in the elimination of cancer cells Two main NK cell subsets have been defined on the basis of CD56 and CD16 expression CD56brightCD16- NK subset produces abundant cytokines including interferon-γ IFN-γ and tumor necrosis factor-α whereas CD56dimCD16 NK subpopulation has high cytolytic activity and releases the granules containing perforin and granzymes
Various clinical studies have been conducted to treat cancers using NK cells worldwide including Korea and therapeutic clinical results are shown for various cancers The clinical application of NK cells is carried out by culturing and activating the NK cells isolated from blood of either patient autologous or blood donor allogeneic Recently NK cell therapy for cholangiocarcinoma has been successfully done NCT03358849 with allogeneic NK cell showing safety and potential efficacy
Like T cells a recent study with digestive cancer has shown that NK cells also express PD-1 especially with more number of PD-1 in cancer patients than in healthy individuals suggesting that blocking PD-1 can be used as a potential strategy to increase the anticancer activity of NK cells Therefore combined therapy with the immune-check point such as pembrolizumab can be useful in elevating the anticancer activity of NK cells
BTC is one of the most prognostic cancer with less than 30 of 5-year survival rate and the case with long-term survival can be possibly done with early detection of the cancer However most of BTC is found in advanced stages due to the difficulty of early detection resulting in that the 5-year survival rate of the advanced BTC becomes less than 3 More than 50 of the patients depends on Gemcitabine based chemotherapy but response rate of the chemotherapy remains around 30 Thus improving the survival rate with the standard chemotherapy is very limited and furthermore selection of second-line therapy is not easy For this reason development of an alternative therapeutic agent is urgently required
NK natural killer cells are important cytotoxic innate immune cells that are involved in the elimination of cancer cells Two main NK cell subsets have been defined on the basis of CD56 and CD16 expression CD56brightCD16- NK subset produces abundant cytokines including interferon-γ IFN-γ and tumor necrosis factor-α whereas CD56dimCD16 NK subpopulation has high cytolytic activity and releases the granules containing perforin and granzymes
Various clinical studies have been conducted to treat cancers using NK cells worldwide including Korea and therapeutic clinical results are shown for various cancers The clinical application of NK cells is carried out by culturing and activating the NK cells isolated from blood of either patient autologous or blood donor allogeneic Recently NK cell therapy for cholangiocarcinoma has been successfully done NCT03358849 with allogeneic NK cell showing safety and potential efficacy
Like T cells a recent study with digestive cancer has shown that NK cells also express PD-1 especially with more number of PD-1 in cancer patients than in healthy individuals suggesting that blocking PD-1 can be used as a potential strategy to increase the anticancer activity of NK cells Therefore combined therapy with the immune-check point such as pembrolizumab can be useful in elevating the anticancer activity of NK cells
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None