OncoMatch/Clinical Trials/NCT05394714
A Phase I, Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection Study
Is NCT05394714 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Magicell-NK contains NK cells suspended in 100 mL normal saline for colon cancer stage i.
Treatment: Magicell-NK contains NK cells suspended in 100 mL normal saline — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage I, IIA
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: colon resection — curative
Received curative colon resection within 4~8 weeks prior to the screening visit and does not need adjuvant chemotherapy or radiotherapy
Cannot have received: investigational, anti-neoplastic medication
Exception: except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only
Received any other investigational, anti-neoplastic medication (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only), or immune cell therapy within 28 days prior to Day 1
Cannot have received: immune cell therapy
Received...immune cell therapy within 28 days prior to Day 1
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1,500 cells/μL; Total white blood cell (WBC) ≥ 3,000 cells/μL; Platelets ≥ 100,000 counts/μL; Hemoglobin ≥ 9 g/dL
Kidney function
Serum creatinine ≤ 1.5 × ULN
Liver function
Serum creatinine ≤ 1.5 × ULN; Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; Alkaline phosphatase ≤ 5X ULN
With adequate hematology function: ANC ≥ 1,500 cells/μL; WBC ≥ 3,000 cells/μL; Platelets ≥ 100,000 counts/μL; Hemoglobin ≥ 9 g/dL. With adequate hepatic and renal function: Serum creatinine ≤ 1.5 × ULN; Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; Alkaline phosphatase ≤ 5X ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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