Advanced Biliary Tract CancerPhase 1NCT03358849
Phase 1 Clinical Trial to Evaluate the Safety of Allogeneic NK Cell ("SMT-NK") Cell Therapy in Advanced Biliary Tract Cancer
A Phase 1 study testing Natural killer cell in people with Advanced Biliary Tract Cancer, run by Yonsei University at 1 site in South Korea.
Trial 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%… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Biliary Tract Cancer
- What is being tested?
- Natural killer cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Oct 2017to 27 Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, 03722
About this study
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.
Read the 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.
- Conditions
- Advanced Biliary Tract Cancer
- Being tested
- Natural killer cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural killer cellBiological
Also called SMT-NK cell
Patients who received natural killer cell injection
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Biological: Natural killer cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity
Adverse event and drug related toxicity will be checked every week by the investigator's monitoring.
Measured: 1 week after NK cell injection
Dose limiting toxicity
Adverse event and drug related toxicity will be checked every week by the investigator's monitoring.
Measured: 2 weeks after NK cell injection
Dose limiting toxicity
Adverse event and drug related toxicity will be checked every week by the investigator's monitoring.
Measured: 3 weeks after NK cell injection
Dose limiting toxicity
Adverse event and drug related toxicity will be checked every week by the investigator's monitoring.
Measured: 4 weeks after NK cell injection
Maximum Tolerated Dose
Adverse event and drug related toxicity will be checked every week by the investigator's monitoring.
Measured: 1 week after NK cell injection
Maximum Tolerated Dose
Adverse event and drug related toxicity will be checked every week by the investigator's monitoring.
Measured: 2 weeks after NK cell injection
Maximum Tolerated Dose
Adverse event and drug related toxicity will be checked every week by the investigator's monitoring.
Measured: 3 weeks after NK cell injection
Maximum Tolerated Dose
Adverse event and drug related toxicity will be checked every week by the investigator's monitoring.
Measured: 4 weeks after NK cell injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start17 Oct 2017
- Primary completion27 Sep 2018
- Study completion27 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358849
- Sponsor's protocol ID
- 4-2016-1165
- Status last verified
- Jan 2019
- First submitted
- 21 Nov 2017
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial to Evaluate the Safety of Allogeneic NK Cell ("SMT-NK") Cell Therapy in Advanced Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT03358849
- Acronym / sponsor ID
- 4-2016-1165
- Conditions
- Advanced Biliary Tract Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 27 Sep 2018 (actual)
- Study completion
- 27 Sep 2018 (actual)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Biological: Natural killer cell |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural killer cellAlso: SMT-NK cellPatients who received natural killer cell injection | Biological | experimental group |
Primary outcome
Dose limiting toxicity
Time frame: 1 week after NK cell injection
Adverse event and drug related toxicity will be checked every week by the investigator's monitoring.
Dose limiting toxicity
Time frame: 2 weeks after NK cell injection
Adverse event and drug related toxicity will be checked every week by the investigator's monitoring.
Dose limiting toxicity
Time frame: 3 weeks after NK cell injection
Adverse event and drug related toxicity will be checked every week by the investigator's monitoring.
Dose limiting toxicity
Time frame: 4 weeks after NK cell injection
Adverse event and drug related toxicity will be checked every week by the investigator's monitoring.
Maximum Tolerated Dose
Time frame: 1 week after NK cell injection
Adverse event and drug related toxicity will be checked every week by the investigator's monitoring.
Maximum Tolerated Dose
Time frame: 2 weeks after NK cell injection
Adverse event and drug related toxicity will be checked every week by the investigator's monitoring.
Maximum Tolerated Dose
Time frame: 3 weeks after NK cell injection
Adverse event and drug related toxicity will be checked every week by the investigator's monitoring.
Maximum Tolerated Dose
Time frame: 4 weeks after NK cell injection
Adverse event and drug related toxicity will be checked every week by the investigator's monitoring.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Advanced Biliary Tract Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
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RecruitingPhase 2
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Colon and Rectal Cancer
RecruitingPhase 2
MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma
Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Natural killer cell in people with Advanced Biliary Tract Cancer, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (time frame: 1 week after NK cell injection). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.