Phase 1/2a clinical trial for the evaluation of safety and efficacy of allogeneic NK cell (SMT-NK”) in combination with Pembrolizumab for patients with Gemcitabine-refractory biliary tract cancer

SMT Bio0 sites40 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

September 30, 2021

Last Updated

3 years ago

Study Type

Interventional Study

Sex

All

Sponsor

SMT Bio

•1\. A person who receives an explanation from the trial manager about the purpose, contents, and characteristics of the Investigational products for the clinical trial and is signed by the person, guardian or legal representative in the written informed consent.
•2\. Be \=19 years of age on day of signing informed consent.
•3\. Histopathological or cytologic diagnosis of advanced adenocarcinoma of the biliary tract.
•4\. Have a performance status of \=2 on the ECOG Performance Scale.
•5\. Patients who survival period is expected to be at least 3 months.
•6\. Patients who meet the following conditions:
•ANC(Absolute Neutrophil Count) \= 1,500/µL
•Hemoglobin\= 10 g/dL
•Platelet\> 100,000/µL
•Serum BUN \& Creatinine \= 1\.5 x upper limit of normal (ULN)

•1\. Patients who have previous history of Immune deficiency or autoimmune disease that can be aggravated by immunotherapy(for example:Rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, Crohn's disease, ulcerative colitis, adolescent\-developed insulin\-dependent diabetes mellitus).
•2\. Diagnosis of immunodeficiency or is receiving systemic steroid therapy.
•3\. Have with pneumonia, colitis, hepatitis, nephritis, endocrine disorders(for example: Pituitary gland, thyroid dysfunction, Type 1 diabetes, etc.) associated with immunodeficiency.
•4\. Other malignant tumors within 5 years before the study enrollment.
•5\. Previous history of anti\-angiogenic agent treatment before the study enrollment.
•6\. Received chemotherapy not less than 4 weeks old before the first administration of investigational products.
•7\. Apparent myocardial infarction or uncontrolled arterial hypertension.
•8\. Serious allergic history.
•9\. Serious mental illness.
•10\. Female who are pregnant, breastfeeding or intending to become pregnant during the study period.