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NCT05394714

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

Recruiting now Phase 1 Last updated 23 September 2025
What this trial tests

Phase 1 trial testing Magicell-NK contains NK cells suspended in 100 mL normal saline in Colon Cancer Stage I in 18 participants. Currently enrolling.

Timeline
10 March 2022
Primary endpoint
31 December 2026
31 December 2026

Quick facts

Lead sponsorMedigen Biotechnology Corporation
PhasePhase 1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsequential
Maskingnone
Primary purposetreatment
Enrollment18
Start date10 March 2022
Primary completion31 December 2026
Estimated completion31 December 2026
Sites1 location across Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

Medigen Biotechnology Corporation — full company profile →

Who can join

20 and older, any sex, with Colon Cancer Stage I. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. NK cells and solid tumors: therapeutic potential and persisting obstacles.
    Tong L, Jiménez-Cortegana C, Tay AHM, Wickström S, et al · · 2022 · cited 134× · PMID 36319998 · DOI 10.1186/s12943-022-01672-z
  2. Redefining cancer care: harnessing circulating tumor cells' potential for improved diagnosis and prognosis.
    Janjua D, Chaudhary A, Joshi U, Tripathi T, et al · · 2025 · cited 4× · PMID 40676582 · DOI 10.1186/s12935-025-03883-y

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Other Medigen Biotechnology Corporation trials

Trials by the same sponsor.

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