Ignite Creation Date:
2024-05-06 @ 5:46 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05429697
Status:
RECRUITING
Last Update Posted:
2022-09-27
First Post:
2022-06-17
Brief Title:
Study of SMT-NK Inj Plus Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract Cancer
Sponsor:
SMT bio Co Ltd
Organization:
SMT bio Co Ltd
Study Overview
Official Title:
Randomized Placebo-controlled Open-label Phase 2b Clinical Trial to Evaluate the Antitumor Activity of Combination Therapy of SMT-NK and Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract Cancer
Status:
RECRUITING
Status Verified Date:
2022-06
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:
This study is designed to assess the antitumor activity of combination therapy of SMT-NK allogeneic natural killer cells and pembrolizumab versus pembrolizumab monotherapy in patients with advanced biliary tract cancer
Detailed Description:
The term of biliary tract cancer BTC refers to all tumors that arise from the biliary tract or the biliary drainage system including the gallbladderBiliary tract cancer is one of the most poorly prognosis cancers and the five-year survival rate remains at about 10 as it is difficult to expect long-term survival due to frequent local recurrence and remote metastasis after surgery
South Korea belongs to a country with a high number of biliary tract cancer patients and the incidence of biliary tract cancer is actually increasing every yearAccording to the 2018 National Cancer Registration Statistics the number of 5-year biliary tract cancer patients was 13967 7547 men and 6420 women which corresponds to about 29 of all cancersand the 5-year survival rate of biliary tract cancer patients between 2014 and 2018 was 288 showing a lower survival rate than other cancer species
Most of the long-term survival is due to early detection by screening but advanced carcinoma is a refractory carcinoma with a 5-year survival rate of less than 5In addition to standard anticancer drugs alternative anticancer drugs and targeted treatments can be developed for cancer with a large number of patients but biliary tract cancer is difficult to find any more treatments if standard treatment fails and standard anticancer treatments cannot be continued due to resistance
Natural killer cells NK cells are innate lymphocyte cells with cell killing activity and have the characteristic of destroying cells by secretion of and granzyme into cancer cells and abnormal cells that are reduced or deficient in expression of MHC class IClinical studies using natural killer cells as anticancer drugs have long been conducted on various cancers
Pembrolizumab is a monoclonal antibody designed to bind to a receptor called PD-1 which is expressed by immune cells such as T cellsNatural killer cells were also found to be expressing PD-1 in the same way as T cells and in particular PD-1 was found to be higher in cancer patients than in healthy people
Therefore combined therapy with the immune-check point such as pembrolizumab can be useful in elevating the anticancer activity of NK cells
South Korea belongs to a country with a high number of biliary tract cancer patients and the incidence of biliary tract cancer is actually increasing every yearAccording to the 2018 National Cancer Registration Statistics the number of 5-year biliary tract cancer patients was 13967 7547 men and 6420 women which corresponds to about 29 of all cancersand the 5-year survival rate of biliary tract cancer patients between 2014 and 2018 was 288 showing a lower survival rate than other cancer species
Most of the long-term survival is due to early detection by screening but advanced carcinoma is a refractory carcinoma with a 5-year survival rate of less than 5In addition to standard anticancer drugs alternative anticancer drugs and targeted treatments can be developed for cancer with a large number of patients but biliary tract cancer is difficult to find any more treatments if standard treatment fails and standard anticancer treatments cannot be continued due to resistance
Natural killer cells NK cells are innate lymphocyte cells with cell killing activity and have the characteristic of destroying cells by secretion of and granzyme into cancer cells and abnormal cells that are reduced or deficient in expression of MHC class IClinical studies using natural killer cells as anticancer drugs have long been conducted on various cancers
Pembrolizumab is a monoclonal antibody designed to bind to a receptor called PD-1 which is expressed by immune cells such as T cellsNatural killer cells were also found to be expressing PD-1 in the same way as T cells and in particular PD-1 was found to be higher in cancer patients than in healthy people
Therefore combined therapy with the immune-check point such as pembrolizumab can be useful in elevating the anticancer activity of NK cells
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