A Phase I, Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection Study

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).

Trial Details

NCT ID
NCT05394714
Phase
PHASE1
Sponsor
Medigen Biotechnology Corporation
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • Magicell-NK contains NK cells suspended in 100 mL normal saline
Locations (sample)
  • Taoyuan, Taiwan|24.99368,121.29696

Key Eligibility Criteria

  • 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

For full eligibility, visit ClinicalTrials.gov.

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