Actively Recruiting
A Phase I, Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection Study
Led by Medigen Biotechnology Corporation · Updated on 2025-09-23
18
Participants Needed
1
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase I, Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent
- Any gender, aged 20 years or older at consent
- Histologically confirmed stage I or stage IIa colon cancer
- Curative colon resection done within 4 to 8 weeks before screening, no need for chemotherapy or radiotherapy
- No grade 3 or higher postoperative complications or fully recovered and suitable for study
- Adequate blood counts: neutrophils ≥ 1,500/μL, white blood cells ≥ 3,000/μL, platelets ≥ 100,000/μL, hemoglobin ≥ 9 g/dL
- Adequate liver and kidney function: creatinine ≤ 1.5× ULN, total bilirubin ≤ 1.5× ULN, ALT and AST ≤ 2.5× ULN, alkaline phosphatase ≤ 5× ULN
- Negative HIV and syphilis tests
- Women with childbearing potential must use effective contraception or abstain from intercourse from consent until study end
- Performance status (ECOG) less than 2
- Agree to comply with the planned treatment protocol
You will not qualify if you...
- Received investigational anti-cancer or immune cell therapy within 28 days before Day 1 (except certain skin cancers treated surgically)
- Currently on immunosuppressive or systemic steroid treatment above prednisolone 30 mg/day for more than 7 days within 14 days before Day 1
- Known tumor spread or other existing malignant diseases
- Serious medical conditions within past 2 years that could affect safety or trial results, including severe heart failure, liver disease (Child-Pugh C), psychiatric conditions, or other significant illnesses
- Known allergy to aminoglycosides or bacitracin
- Known allergy to any Magicell-NK components, including human serum albumin
- Female participants who are breastfeeding or have a positive pregnancy test at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan, 333
Actively Recruiting
Research Team
J
Jude Chen
CONTACT
C
Chiachien Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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