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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    18
  • sponsor
    Medigen Biotechnology Corporation
Updated on 24 October 2022

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 (2×108 cells), Cohort 2, middle dose (6×108 cells), and Cohort 3, high dose (18 ×108 cells).

Details
Condition Colon Cancer Stage I
Treatment Magicell-NK contains NK cells suspended in 100 mL normal saline
Clinical Study IdentifierNCT05394714
SponsorMedigen Biotechnology Corporation
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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