Phase I/II Study: Allogeneic NK-cell Therapy With Chemotherapy for Post-Surgery PDA or Cholangiocarcinoma Patients

Inclusion Criteria:

1. Dated and signed informed consent

2. Either sex, aged older than 18 years old (inclusive) at date of consent

3. Subject with a macroscopic resection of the primary tumor and residual primary tumorthat satisfies all of the items below according to the Union for InternationalCancer Control (UICC) histopathologic staging system:

• At or before the surgery, stage II or stage III where resection included theceliac artery

• Local residual tumor classified as R0 or R1

• Cytologic examination negative upon intraoperative peritoneal lavage

4. Histologically confirmed PDA or cholangiocarcinoma

5. Received curative resection within 12 weeks prior to screening visit and willreceive adjuvant SLOG chemotherapy Note: Subjects with cancer who had undergonesurgery with or without prior neo-adjuvant therapy will be recruited.

6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

7. Subject with adequate hematology function at Visit 1:

• Total white blood cell (WBC) ≥ 3,000 cells/mm3

• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3

• Platelets ≥ 100,000 counts/mm3

• Hemoglobin ≥ 9 g/dL

• International normalized ratio (INR) of prothrombin time within normal rangeNote: Re-test for eligibility is allowed during the screening period.

8. Subject with adequate hepatic and renal function at Visit 1:

• Serum creatinine ≤ 1.5× Upper Limit of Normal (ULN)

• Blood urea nitrogen (BUN) ≤ 1.5× ULN

• Total bilirubin ≤ 1.5× ULN

• Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5× ULN

• Alkaline phosphatase (ALP) ≤ 5× ULN

• Albumin ≥ 3.0 g/dL Note: Re-test for eligibility is allowed during thescreening period.

9. Negative response in human immunodeficiency virus (HIV) and treponema pallidum (rapid plasma reagin [RPR]/venereal disease research laboratory [VDRL] and treponemapallidum hemagglutination [TPHA])

10. Subject confirmed with past cytomegalovirus (CMV) infection in terms of havingpositive CMV immunoglobin G (CMV IgG)

11. Subject with childbearing potential must agree to use at least two contraceptiveprecautions, one of which must be a condom or other adequate barrier method, from

• signing informed consent until 28 days after the last dose of investigationalproduct (IP) administration

• initiation of oxaliplatin treatment until at least 15 months (female) or 12months (male) following the last dose

• initiation of gemcitabine treatment until at least 6 months (female) or 3months (male) following the last dose

12. Agree to be in compliance with clinical protocol-planned treatment Note: Anti-virustreatment is allowed if active hepatitis B is presented.

Exclusion Criteria:

1. Received any other investigational, anti-neoplastic medications, or immune celltherapy within 28 days prior to screening visit

2. Any prior history of malignant neoplasm, except:

3. Non-invasive, non-melanomatous skin cancer (including squamous cell carcinoma,basal cell carcinoma, or carcinoma in situ), curatively treated withcryosurgery or surgical excision only

4. Other primary malignant neoplasm diagnosed as disease free for more than 5years

5. Immunocompromized, currently under immunosuppressive treatment for autoimmunedisease, or have received systemic steroid of equivalent dosage higher thanprednisolone 30 mg/day for more than 7 days within 14 days prior to Day 1

6. With known metastases

7. With ongoing acute diseases, or serious medical conditions within the past 2 yearsprior to screening, such as cardiovascular (e.g., New York Heart Association gradeIII or IV), hepatic (e.g., Child-Pugh Class C), psychiatric condition (e.g.,alcoholism, drug abuse), medical history, physical findings, or laboratoryabnormality that in the investigators' opinion could interfere with the results ofthe trial or adversely affect the safety of the subject

8. Hypercoagulable state that may lead to clinically apparent thrombosis

9. With known hypersensitivity to aminoglycoside (e.g., streptomycin, gentamicin) orbacitracin

10. With known hypersensitivity to any of the components of Allogeneic Magicell-NK,including human serum albumin

11. With known hypersensitivity to any of the components of S 1, leucovorin,oxaliplatin, or gemcitabine

12. With any contraindication to S-1, leucovorin, oxaliplatin, or gemcitabine,including:

• Severe myelosuppression or myelosuppression that probably exacerbates

11. With symptomatic CMV disease

12. With any history of diagnosed or suspected cardiac arrhythmia or QT intervalprolongation

13. Male subject with a corrected QT interval (QTc) ≥ 450 ms and female subject with aQTc ≥ 470 ms as determined by electrocardiogram (ECG) examination at screening.

14. Received any drugs associated with QT prolongation within 28 days prior to theScreening Visit (refer to Appendix 3. Drugs Associated with QT Prolongation,including but not limited to the drug listed therein)

15. Received brivudine or its analogs (e.g., sorivudine) or any live vaccines within 28days prior to the Screening Visit

16. Female subject who is lactating or has positive serum or urine pregnancy test atscreening