drugset / Trial / NCT05394714
A Phase I, Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection Study
NaSequentialOpen-labelTreatment
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).
Timeline
- Start
- 2022-03-10
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Magicell-NK | Cell therapy | 2e+08 cells | Other |
| Subject | Magicell-NK | Cell therapy | 6e+08 cells | Other |
| Subject | Magicell-NK | Cell therapy | 1.2e+09 cells | Other |
| Subject | Magicell-NK | Cell therapy | 1.8e+09 cells | Other |