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

NCT05394714 | Recruiting Phase 1 DMC

• 1 other identifier: CT-NK-11
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Colon Cancer Stage I

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs)

  Number of participants with serious adverse events and treatment emergent adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) to assess tolerability of Magicell-NK treatment. Evaluation of side effects conducted during the study period. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

  Up to 60 weeks

• Number of Participants With at Least One Dose Limiting Toxicity

  Dose Limiting Toxicity (DLT) as defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 as treatment-related any greater or equal to Grade 4 adverse event of hematologic toxicity, or any greater or equal to Grade 3 adverse event of non-hematologic toxicity during Visit 3\~ visit 10. With the exception of (1) fever grade 3 or grade 4 which is controllable by antihistamine and resolves to grade 2 or less within 48 hours, (2) hypersensitivity reactions occurring within 2 hours of infusion finished (related to cell infusion) that are reversible to a grade 2 or less within 48 hours with standard therapy, (3) grade 3 electrolyte imbalance or dehydration that resolves to grade 1 or less within 48 hours, (4) grade 3 nausea, vomiting, or diarrhea which is controllable by standard medication that resolves to grade 1 or less within 48 hours, (5) fatigue which resolves to grade 1 or less within 7 days.

  Within 14-day observation of the first treatment. up to 60 weeks

• Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D)

  MTD is defined as the highest dose level at which ≤ 1/6 of subjects experiences DLT during Visit 3\~10, when at least 6 patients are treated at that dose and are evaluable for toxicity. Dose escalations proceeded according to a standard 3+3 design. Maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of therapy was determined by monitoring dose-limiting toxicity and adverse events in the dosing cohorts

  3 weeks from start of treatment, up to 60 weeks

Secondary Outcomes (4)

• Disease free survival (DFS)

  Up to 60 weeks

• Changes in Frequency and Duration of ctDNA

  Up to 60 weeks

• Changes in Frequency and Duration of Circulating Tumor Count (CTC) and Programmed Death-Ligand 1 Circulating Tumor Count (PD-L1+ CTC) counts

  Up to 60 weeks

• Changes in Biomarkers (CEA and CA19-9)

  Up to 60 weeks

Study Arms (1)

Magicell-NK

EXPERIMENTAL

Magicell-NK Cohort 1: 2 x 10\^8 cells x 6 infusions Cohort 2: 6 x 10\^8 cells x 6 infusions Cohort 3: 12\~18 x 10\^8 cells x 6 infusions

Biological: Magicell-NK contains NK cells suspended in 100 mL normal saline

Interventions

Magicell-NK contains NK cells suspended in 100 mL normal saline BIOLOGICAL

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

Magicell-NK

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medigen Biotechnology Corporation: lead

Study Sites (1)

Chang Gung Memorial Hospital, Linkou

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Stanley Chang, PhD

  Medigen Biotechnology Corporation

  STUDY CHAIR

Central Study Contacts

Jude Chen

CONTACT

886-2-7722-5200; jude@medigen.com.tw

Chiachien Lee

CONTACT

886-2-7722-5200; chiachien.lee@medigen.com.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 27, 2022
• Study Start: March 10, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)