Phase 1 Clinical Trial to Evaluate the Safety of Allogeneic NK Cell ("SMT-NK") Cell Therapy in Advanced Biliary Tract Cancer

January 15, 2019 updated by: Yonsei University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental group
Biological: Natural killer cell
Patients who received natural killer cell injection
Other Names:
  • SMT-NK cell

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 week after NK cell injection
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.
2 weeks after NK cell injection
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.
3 weeks after NK cell injection
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.
4 weeks after NK cell injection
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.
1 week after NK cell injection
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.
2 weeks after NK cell injection
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.
3 weeks after NK cell injection
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.
4 weeks after NK cell injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 27, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 27, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4-2016-1165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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