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New treatment option for Colon Cancer Stage I
Official title A Phase I, Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection Study
ClinicalTrials.gov ID: NCT05394714
What this study is testing
What is Magicell-NK contains NK cells suspended in 100 mL normal saline?
Magicell-NK contains NK cells suspended in 100 mL normal saline is an investigational medicine, being studied as a potential treatment for colon cancer stage i.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- 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
You likely can't join if
- Received any other investigational, anti-neoplastic medication (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the...
- Currently under immunosuppressive or systemic steroid treatment with equivalent dosage higher than prednisolone 30 mg/day for more than 7 days within...
- 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...
- Known hypersensitivity to aminoglycoside or bacitracin (e.g. Streptomycin, Gentamicin)
- Known hypersensitivity to any of the components of Magicell-NK, including human serum albumin
See the full eligibility 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
- 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...
- 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...
- 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 study team makes the final eligibility decision.
Where it's taking place
- Taoyuan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taoyuan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.