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 tumor that satisfies all of the items below according to the Union for International Cancer Control (UICC) histopathologic staging system:
• •* At or before the surgery, stage II or stage III.
• •* 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 will receive adjuvant SLOG chemotherapy. Note: Subjects with cancer who had undergone surgery 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 range. Note: 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 the screening period.
• •9. Negative response in human immunodeficiency virus (HIV) and treponema pallidum (rapid plasma reagin \[RPR\]/venereal disease research laboratory \[VDRL\] and treponema pallidum hemagglutination \[TPHA\]).
• •10. Subject confirmed with past cytomegalovirus (CMV) infection in terms of having positive CMV immunoglobin G (CMV IgG).
• •11. Subject with childbearing potential must agree to use at least two contraceptive precautions, one of which must be a condom or other adequate barrier method, from
• •* signing informed consent until 28 days after the last dose of investigational product (IP) administration.
• •* initiation of oxaliplatin treatment until at least 15 months (female) or 12 months (male) following the last dose.
• •* initiation of gemcitabine treatment until at least 6 months (female) or 3 months (male) following the last dose.
• •12. Agree to be in compliance with clinical protocol-planned treatment. Note: Anti-virus treatment is allowed if active hepatitis B is presented.