Clinical Trials List
Protocol NumberCT-NK-11
NCT Number(ClinicalTrials.gov Identfier)NCT05394714
Active
2021-11-01 - 2026-12-31
Phase I
Recruiting1
ICD-10C18.3
Malignant neoplasm of hepatic flexure
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9153.0
Malignant neoplasm of hepatic flexure colon
A Dose-Escalating Phase I Study to Determine the Safety, and Maximum Tolerated Dose/ Maximum Feasible Dose of Autologous ex vivo Expanded and Activated NK cell, Magicell-NK, Infusion for Colon Cancer post Resection
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Trial Applicant
A2 HEALTHCARE TAIWAN CORPORATION
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Sponsor
Medigen Biotechnology Corporation
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Trial scale
Taiwan Single Center
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Update
2026/03/01
Investigators and Locations
Linkou Chang Gung Medical Foundation
Chairman/Global PI
廖俊凱
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Colon Cancer Stage I/IIa
Objectives
主要目的：
(1)To assess the clinical safety profiles of Magicell-NK in subjects with stage I or IIa colon cancer post resection
(2)To assess the Dose Limiting Toxicity (DLT) of Magicell-NK
(3)To determine the Maximum Tolerated Dose (MTD)/Maximum Feasible Dose (MFD) of Magicell-NK
次要目的：
(1)To evaluate the antitumor efficacy of Magicell-NK
(2)To evaluate the immune response of Magicell-NK
(3)To evaluate the change in levels of circulating tumor DNA (ctDNA), circulating tumor cell (CTC), programme
Test Drug
Magicell-NK
Active Ingredient
Autologous NK cells
Dosage Form
Solution
Dosage
2~18×108 /100 mL
Endpoints
主要目的：
(1)To assess the clinical safety profiles of Magicell-NK in subjects with stage I or IIa colon cancer post resection
(2)To assess the Dose Limiting Toxicity (DLT) of Magicell-NK
(3)To determine the Maximum Tolerated Dose (MTD)/Maximum Feasible Dose (MFD) of Magicell-NK
次要目的：
(1)To evaluate the antitumor efficacy of Magicell-NK
(2)To evaluate the immune response of Magicell-NK
(3)To evaluate the change in levels of circulating tumor DNA (ctDNA), circulating tumor cell (CTC), programme
(1)To assess the clinical safety profiles of Magicell-NK in subjects with stage I or IIa colon cancer post resection
(2)To assess the Dose Limiting Toxicity (DLT) of Magicell-NK
(3)To determine the Maximum Tolerated Dose (MTD)/Maximum Feasible Dose (MFD) of Magicell-NK
次要目的：
(1)To evaluate the antitumor efficacy of Magicell-NK
(2)To evaluate the immune response of Magicell-NK
(3)To evaluate the change in levels of circulating tumor DNA (ctDNA), circulating tumor cell (CTC), programme
Inclution Criteria
Inclusion Criteria:
A dated and signed informed consent
Either gender and aged over 20 years old (inclusive) at date of consent
With histologically confirmed stage I or stage IIa colon cancer
Received curative colon resection within 4~8 weeks prior to the screening visit and does not need adjuvant chemotherapy or radiotherapy
With no ≥ grade 3 postoperative complications or has been recovered and is suitable for study enrollment according to the investigator's judgment
With adequate hematology function:
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
With adequate hepatic and renal function:
Serum creatinine ≤ 1.5 × Upper Limit of Normal (ULN)
Total bilirubin (TB) ≤ 1.5 × ULN
ALT and AST ≤ 2.5 × ULN
Alkaline phosphatase (ALP) ≤ 5X ULN
Negative response in HIV and syphilis test
Subject with childbearing potential must agree to abstain from intercourse or use highly effective contraceptives from when signing informed consent to the Final/ET Visit.
Performance status (ECOG) < 2
Patients agree to be in compliant to clinical protocol planned treatment plan
A dated and signed informed consent
Either gender and aged over 20 years old (inclusive) at date of consent
With histologically confirmed stage I or stage IIa colon cancer
Received curative colon resection within 4~8 weeks prior to the screening visit and does not need adjuvant chemotherapy or radiotherapy
With no ≥ grade 3 postoperative complications or has been recovered and is suitable for study enrollment according to the investigator's judgment
With adequate hematology function:
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
With adequate hepatic and renal function:
Serum creatinine ≤ 1.5 × Upper Limit of Normal (ULN)
Total bilirubin (TB) ≤ 1.5 × ULN
ALT and AST ≤ 2.5 × ULN
Alkaline phosphatase (ALP) ≤ 5X ULN
Negative response in HIV and syphilis test
Subject with childbearing potential must agree to abstain from intercourse or use highly effective contraceptives from when signing informed consent to the Final/ET Visit.
Performance status (ECOG) < 2
Patients agree to be in compliant to clinical protocol planned treatment plan
Exclusion Criteria
Exclusion Criteria:
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.
Currently under immunosuppressive or systemic steroid treatment with equivalent dosage higher than prednisolone 30 mg/day for more than 7 days within 14 days prior to Day 1
With known tumor metastasis or coexisting malignant disease
With ongoing acute diseases, or within the past 2 years having serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that, judged by the investigator, could interfere with the results of the trial or adversely affect the safety of the subject
Known hypersensitivity to aminoglycoside or bacitracin (e.g. Streptomycin, Gentamicin)
Known hypersensitivity to any of the components of Magicell-NK, including human serum albumin
Female subject who is lactating or has positive urine pregnancy test at screening
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.
Currently under immunosuppressive or systemic steroid treatment with equivalent dosage higher than prednisolone 30 mg/day for more than 7 days within 14 days prior to Day 1
With known tumor metastasis or coexisting malignant disease
With ongoing acute diseases, or within the past 2 years having serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that, judged by the investigator, could interfere with the results of the trial or adversely affect the safety of the subject
Known hypersensitivity to aminoglycoside or bacitracin (e.g. Streptomycin, Gentamicin)
Known hypersensitivity to any of the components of Magicell-NK, including human serum albumin
Female subject who is lactating or has positive urine pregnancy test at screening
The Estimated Number of Participants
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Taiwan
18 participants
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Global
18 participants
