Infusion of activated NK cells for post-surgery colon cancer treatment
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
This study is testing a new treatment using special immune cells to see if it can safely help people with early-stage colon cancer after their surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Medigen Biotechnology Corporation Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Taoyuan) |
| Trial ID | NCT05394714 on ClinicalTrials.gov |
What this trial studies
This Phase I open-label study investigates the safety and maximum tolerated dose of Magicell-NK, an infusion of autologous expanded and activated natural killer (NK) cells, in patients with stage I or stage IIa colon cancer following surgical resection. The study employs a 3+3 design to evaluate three different dose levels of NK cells. Participants will be monitored for safety and tolerability to determine the optimal dosing for future studies.
Who should consider this trial
Good fit: Ideal candidates are adults over 20 years old with histologically confirmed stage I or stage IIa colon cancer who have undergone curative resection within the last 4 to 8 weeks.
Not a fit: Patients with advanced colon cancer requiring adjuvant chemotherapy or those with significant postoperative complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance the immune response against colon cancer, potentially improving patient outcomes post-surgery.
How similar studies have performed: While similar approaches using NK cell therapies have shown promise in other cancers, this specific application in early-stage colon cancer is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. A dated and signed informed consent 2. Either gender and aged over 20 years old (inclusive) at date of consent 3. With histologically confirmed stage I or stage IIa colon cancer 4. Received curative colon resection within 4\~8 weeks prior to the screening visit and does not need adjuvant chemotherapy or radiotherapy 5. With no ≥ grade 3 postoperative complications or has been recovered and is suitable for study enrollment according to the investigator's judgment 6. 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 7. 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 8. Negative response in HIV and syphilis test 9. 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. 10. Performance status (ECOG) \< 2 11. Patients agree to be in compliant to clinical protocol planned treatment plan Exclusion Criteria: 1. 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. 2. 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 3. With known tumor metastasis or coexisting malignant disease 4. 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 5. Known hypersensitivity to aminoglycoside or bacitracin (e.g. Streptomycin, Gentamicin) 6. Known hypersensitivity to any of the components of Magicell-NK, including human serum albumin 7. Female subject who is lactating or has positive urine pregnancy test at screening
Where this trial is running
Taoyuan
- Chang Gung Memorial Hospital, Linkou — Taoyuan, Taiwan (Recruiting)
Study contacts
- Study coordinator: Jude Chen
- Email: jude@medigen.com.tw
- Phone: 886-2-7722-5200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.