A Phase I, Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Can… (NCT05394714) | Clinical Trial Compass
RecruitingPhase 1
A Phase I, Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection Study
Taiwan18 participantsStarted 2022-03-10
Plain-language summary
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).
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
. With adequate hepatic and renal function:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs)
Timeframe: Up to 60 weeks
2
Number of Participants With at Least One Dose Limiting Toxicity
Timeframe: Within 14-day observation of the first treatment. up to 60 weeks
3
Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D)
Timeframe: 3 weeks from start of treatment, up to 60 weeks
. 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