A Dose-Escalating Phase I Study to Determine the Safety, and Maximum Tolerated Dose/ Maximum Feasible Dose of Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection
This is a Phase I, open-label study to explore the safety profile and to find the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of Magicell-NK in subjects diagnosed with stage I or stage IIa colon cancer post resection from a single site in Taiwan. During this study, 3 dose levels of Magicell-NK will be tested with a 3+3 design to determine the MTD/MFD: Cohort 1, low dose (2×10\^8 cells), Cohort 2, middle dose (6×10\^8 cells), and Cohort 3, high dose (12\ 18 ×10\^8 cells).
• A dated and signed informed consent
• Either gender and aged over 20 years old (inclusive) at date of consent
• With histologically confirmed stage I or stage IIa colon cancer
• Received curative colon resection within 4\
∙ 8 weeks prior to the screening visit and does not need adjuvant chemotherapy or radiotherapy
• With no ≥ grade 3 postoperative complications or has been recovered and is suitable for study enrollment according to the investigator's judgment
• With adequate hematology function:
‣ Absolute neutrophil count (ANC) ≥ 1,500 cells/μL
⁃ Total white blood cell (WBC) ≥ 3,000 cells/μL
⁃ Platelets ≥ 100,000 counts/μL
⁃ Hemoglobin ≥ 9 g/dL
• With adequate hepatic and renal function:
‣ Serum creatinine ≤ 1.5 × Upper Limit of Normal (ULN)
⁃ Total bilirubin (TB) ≤ 1.5 × ULN
⁃ ALT and AST ≤ 2.5 × ULN
⁃ Alkaline phosphatase (ALP) ≤ 5X ULN
• Negative response in HIV and syphilis test
• Subject with childbearing potential must agree to abstain from intercourse or use highly effective contraceptives from when signing informed consent to the Final/ET Visit.
⁃ Performance status (ECOG) \< 2
⁃ Patients agree to be in compliant to clinical protocol planned treatment plan