RecruitingPhase 1NCT05394714

A Phase I, Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection Study

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

Sponsor

Medigen Biotechnology Corporation

Enrollment

18 participants

Start Date

Mar 10, 2022

Study Type

INTERVENTIONAL

Conditions

Colon Cancer Stage I

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).

Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether infusing specially prepared natural killer (NK) immune cells — grown from your own blood — can help prevent colon cancer from coming back after surgery. **You may be eligible if...** - You are 20 years old or older - You have been diagnosed with early-stage (Stage I or IIa) colon cancer - You had surgery to remove the cancer within the past 4–8 weeks - Your doctor determined you do not need additional chemotherapy or radiation after surgery - Your blood counts and organ function are in a healthy range **You may NOT be eligible if...** - You are currently on immunosuppressive drugs or high-dose steroids - You have cancer that has spread or another active cancer - You have HIV or syphilis - You received another experimental treatment or immune cell therapy within the past 28 days - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMagicell-NK contains NK cells suspended in 100 mL normal saline

Eligible subjects will be assigned into one of the three dose escalating cohorts (3+3 subjects/cohort) according to the time sequence enrolled

Locations(1)

Chang Gung Memorial Hospital, Linkou

Taoyuan, Taiwan

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NCT05394714