Investigator-initiated Pilot Study to Investigate the Efficacy and Safety of Immuncell-LC in Combination With Nivolumab (Opdivo) in Subjects With Advanced or Recurrent Gastric Cancer

Inclusion Criteria:

1. Adult males and females aged 19 years or above
2. Histologically and/or cytologically confirmed unresectable advanced/relapsed gastricadenocarcinoma or gastro-esophageal junction cancer that meets one of the followingcriteria: A. Confirmed relapsed or advanced gastric adenocarcinoma or gastro-esophageal junctioncancer after at least two prior chemotherapies (Perioperative, neoadjuvant, andadjuvant chemotherapy are not considered as prior chemotherapies, but if the diseaseprogression occurs during or within 6 months of completion of adjuvant chemotherapy,it is considered a prior chemotherapy). B. Patients who are not eligible for standard anti-cancer treatments due tocontraindications, intolerance, etc. or who have no other standard treatmentsavailable for refusing the treatment may be enrolled at the judgement of theinvestigator regardless of the number of prior chemotherapies.
3. A measurable lesion based on RECIST v1.1 (Irradiated area will be consideredmeasurable if PD is confirmed in the area).
4. The Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-1
5. Life expectancy of at least 12 weeks
6. Confirmed adequate hematological, hepatic, renal and coagulation functions as follows: A. Hematological function: absolute neutrophil count (ANC) ≥ 1,500/μL, hemoglobin ≥ 9g/dL, platelet count ≥ 100,000/μL B. Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit normal (ULN), totalbilirubin ≤ 1.0 × ULN (if liver metastasis is confirmed, AST/ALT < 3 × ULN) C. Renalfunction: blood urine nitrogen (BUN) and serum creatinine ≤ 1.5 × ULN D. Bloodcoagulation:prothrombin time (PT) (international normalized ratio, INR) and activatedpartial thromboplastin time (aPTT) ≤ 1.5 × ULN
7. Fully understood the study information (purpose, procedure, etc.) and voluntarilyprovided a written consent to participate in this study.

Exclusion Criteria:

• 1. Prior treatment with any cell therapy products including but not limited toImmuncell-LC or natural killer (NK) cell therapy products

2. Prior immuno-oncology agents such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137,and anti-CTLA-4
3. Hypersensitivity to the active ingredient or excipients of Immuncell-LC ornivolumab
4. Unable to collect autologous blood for production of Immuncell-LC at the judgementof the investigator
5. History of anti-cancer treatment (chemotherapy, targeted therapy [within 4 weeksfor monoclonal antibody], radiation therapy, etc.) within 2 weeks prior to screening
6. An adverse event (AE) with prior treatments that is not resolved (CTCAE grade ≤ 1or baseline) (with the exceptions of peripheral neuropathy or alopecia that are ≥grade 2)
7. History of immunosuppressive drugs within 2 weeks prior to screening (with theexceptions of topical, ophthalmic, intra-articular, intranasal, or inhalationalcorticosteroids, or systemic corticosteroids at doses, which are not to exceed 10mg/day of prednisone, or an equivalent corticosteroid)
8. Administration of live vaccines, live attenuated vaccines, or inactivated vaccineswithin 4 weeks prior to screening
9. The following medical history confirmed at screening: A. Confirmed diagnosis ofhuman immunodeficiency virus (HIV) (HIV 1/2 antibodies) which could worsen byimmunotherapy B. History of an active immune disease (e.g. rheumatoid arthritis,inflammatory bowel disease, systemic lupus erythematosus, vasculitis, multiplesclerosis, T cell lymphoma) with systemic treatment (disease controllers,corticosteroids, immunosuppressants, etc.) within 2 years prior to screening (Alternative therapies [e.g., thyroxine, insulin, physiologic replacement therapy withcorticosteroids for adrenal or pituitary insufficiency] are not considered as systemictreatments) C. History of interstitial lung disease D. Concurrent infection or sepsisE. Evident myocardial failure or uncontrolled arterial hypertension F.Gastrointestinal perforation or fistula G. History of other malignant tumors excludinggastric adenocarcinoma/gastro-esophageal junction cancer within 5 years prior toscreening (If the investigator determines that basal cell carcinoma/squamous cellcarcinoma of the skin, localized prostate cancer, papillary thyroid carcinoma, orcervical carcinoma in situ is cured after successful treatment, the patients areeligible to participate even if 5 years have not passed)
10. The following concomitant diseases at screening that may affect the safety andefficacy assessments during the study at the judgement of the investigator: A.Clinically significant pericardial effusion, pleural effusion or ascites (e.g.,requiring treatment) B. Clinically significant symptoms or uncontrolled centralnervous system or brain metastases or carcinomatous meningitis (except if progressionis not confirmed clinically and on CT/MRI for at least 4 weeks before administrationof the IP and treatment with steroids, etc. is not required for 7 days beforeadministration of the IP after treatment of central nervous system or brainmetastases.) C. Diseases that may clinically increase the risk of gastrointestinalbleeding (e.g., active diverticulitis, gastro-intestinal ulcerative disease or diseasethat can increase the risk of perforation) D. Active hepatitis B (HbsAg positive) or C (The patients are eligible to participate in the study even if HCV antibody ispositive as long as RNA is negative, as it will be considered as a prior infection) E.Severe infections or other uncontrolled active infectious diseases requiringadministration of antibiotics, antivirals, etc. that may affect the safety andefficacy assessments during the study F. Thromboembolic diseases or bleeding diathesesG. Considered ineligible to participate in the study due to concomitant disease thatis uncontrolled or requires treatment (e.g., heart disease, decreased lung function,decreased kidney function, hypotension, hypertension, findings of myelosuppression,hepatitis, liver cirrhosis, history of alcohol addiction, myocardial infarction)
11. Pregnant or breast-feeding women, or women who intend to become pregnant
12. Received other IP or used an investigational device within 4 weeks prior toscreening
13. Ineligible or unable to participate in the study at the judgement of theinvestigator