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

NCT03358849 | Completed Phase 1

• 1 other identifier: 4-2016-1165
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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% 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.

Conditions

Advanced Biliary Tract Cancer

Outcome Measures

Primary Outcomes (8)

• Dose limiting toxicity

  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

  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

  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

  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

  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

  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

  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

  Adverse event and drug related toxicity will be checked every week by the investigator's monitoring.

  4 weeks after NK cell injection

Study Arms (1)

experimental group

EXPERIMENTAL

Biological: Natural killer cell

Interventions

Natural killer cell BIOLOGICAL

Patients who received natural killer cell injection

Also known as: SMT-NK cell

experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• y≤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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 2, 2017
• Study Start: October 17, 2017
• Primary Completion: September 27, 2018
• Study Completion: September 27, 2018
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)