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A Phase I, Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection Study
Sponsor: Medigen Biotechnology Corporation
Summary
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).
Official title: 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
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2022-03-10
Completion Date
2026-12-31
Last Updated
2025-09-23
Healthy Volunteers
No
Conditions
Interventions
Magicell-NK contains NK cells suspended in 100 mL normal saline
Eligible subjects will be assigned into one of the three dose escalating cohorts (3+3 subjects/cohort) according to the time sequence enrolled
Locations (1)
Chang Gung Memorial Hospital, Linkou
Taoyuan District, Taiwan