A Phase I, Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection Study
Recruiting
Phase 1
Interventional Study
Colon Cancer Stage I
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 20 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 18 (estimated)
- Sponsor
- Medigen Biotechnology Corporation · Industry
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About This Trial
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 c…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. A dated and signed informed consent
2. Either gender and aged over 20 years old (inclusive) at date of consent
3. With histologically confirmed stage I or stage IIa colon cancer
4. Received curative colon resection within 4\~8 weeks prior to the screening visit and does not n…
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