Phase 1 Clinical Trial to Evaluate the Safety of Allogeneic NK Cell (“SMT-NK”) C

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

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https://clinicaltrials.gov/ct2/show/NCT03358849

PurposeCholangiocarcinoma 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.

Condition
Intervention
Phase
Advanced Biliary Tract Cancer
Biological: Natural killer cell
Phase 1

Study Type:
Interventional
Study Design:
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title:
Phase 1 Clinical Trial to Evaluate the Safety of Allogeneic NK Cell (“SMT-NK”) Cell Therapy in Advanced Biliary Tract Cancer

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Biliary Tract Cancer
U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures: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.

Estimated Enrollment:
12
Actual Study Start Date:
October 1, 2017
Estimated Study Completion Date:
August 2018
Estimated Primary Completion Date:
August 2018 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions
Experimental: experimental group
Biological: Natural killer cellPatients who received natural killer cell injection
Other Name: SMT-NK cell

Show Detailed Description

Eligibility
Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:
18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Criteria
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
Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358849

Locations

Korea, Republic of
Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine
Recruiting
Seoul, Korea, Republic of, 03722
Contact: Seung Woo Park, MD, Ph.D    82-2-2228-1964    swoopark@yuhs.ac
Sponsors and Collaborators
Yonsei University
More Information

Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT03358849     History of Changes
Other Study ID Numbers:
4-2016-1165

First Submitted:
November 21, 2017
First Posted:
December 1, 2017
Last Update Posted:
December 1, 2017
Last Verified:
November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No

Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No