Colon Cancer Stage IPhase 1NCT05394714
A Phase I, Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection Study
A Phase 1 study testing Magicell-NK contains NK cells suspended in 100 mL normal saline in people with Colon Cancer Stage I, run by Medigen Biotechnology Corporation at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colon Cancer Stage I
- What is being tested?
- Magicell-NK contains NK cells suspended in 100 mL normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Mar 2022to 30 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 19Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333
Chun Kai Liao, M.D., 886-3-3281200 ext. 2101, mr9023@cgmh.org.tw
Chun Kai Liao, M.D.
About this study
Official title: 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 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
- Being tested
- Magicell-NK contains NK cells suspended in 100 mL normal saline
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magicell-NK contains NK cells suspended in 100 mL normal salineBiological
Eligible subjects will be assigned into one of the three dose escalating cohorts (3+3 subjects/cohort) according to the time sequence enrolled
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Magicell-NK contains NK cells suspended in 100 mL normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 3 weeks from start of treatment, up to 60 weeks
Secondary outcomes (4)
Disease free survival (DFS)
The time from the date of the first Magicell-NK infusion to the date of the first disease-free survival event (recurrence, second primary colon cancer or death from any cause).
Measured: Up to 60 weeks
Changes in Frequency and Duration of ctDNA
Number of participants experiencing ctDNA seroconversion (i.e. ctDNA+ that become ctDNA-) after any Magicell-NK regimen remaining disease free. Change in values will be tabulated descriptively by visit with 95% two-sided confidence interval.
Measured: 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
Determine the effect of Magicell-NK on reducing CTC and PD-L1+ CTC of whole blood in colon cancer with elevated baseline CTC count and PD-L1+ CTC to identify the least effective dose that clears CTCs and PD-L1+ CTC. Baseline count of CTC and PD-L1+ CTC will be recorded prior to before Magicell-NK therapy in a whole blood sample. Count of CTC and PD-L1+ CTC will be measured at 1 week (post treatment evaluation visit), and 10-12 weeks (follow up visits) after Magicell-NK therapy in a whole blood sample. These values will be compared.
Measured: Up to 60 weeks
Changes in Biomarkers (CEA and CA19-9)
Determine the effect of Magicell-NK on CEA and CA 19-9 in colon cancer with elevated baseline CEA and CA 19-9 to identify the least effective dose that clears CEA and CA 19-9. Baseline count of CEA and CA 19-9 will be recorded prior to before Magicell-NK therapy. Count of CEA and CA 19-9 will be measured at 1 week (post treatment evaluation visit), and 10-12 weeks (follow up visits) after Magicell-NK therapy. These values will be compared.
Measured: Up to 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start10 Mar 2022
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer Stage IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medigen Biotechnology Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stanley Chang, PhD, Study chair, Medigen Biotechnology Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394714
- Sponsor's protocol ID
- CT-NK-11
- Status last verified
- Jul 2026
- First submitted
- 11 May 2022
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05394714
- Acronym / sponsor ID
- CT-NK-11
- Conditions
- Colon Cancer Stage I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Medigen Biotechnology CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magicell-NK | Experimental | Biological: Magicell-NK contains NK cells suspended in 100 mL normal salineMagicell-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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magicell-NK contains NK cells suspended in 100 mL normal salineEligible subjects will be assigned into one of the three dose escalating cohorts (3+3 subjects/cohort) according to the time sequence enrolled | Biological | Magicell-NK |
Primary outcome
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 60 weeks
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.
Number of Participants With at Least One Dose Limiting Toxicity
Time frame: Within 14-day observation of the first treatment. up to 60 weeks
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.
Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D)
Time frame: 3 weeks from start of treatment, up to 60 weeks
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
4 secondary outcomes
Disease free survival (DFS)
Time frame: Up to 60 weeks
Changes in Frequency and Duration of ctDNA
Time frame: 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
Time frame: Up to 60 weeks
Changes in Biomarkers (CEA and CA19-9)
Time frame: Up to 60 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stanley Chang, PhD study chair
Medigen Biotechnology Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Magicell-NK contains NK cells suspended in 100 mL normal saline in people with Colon Cancer Stage I, run by Medigen Biotechnology Corporation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jude Chen (886-2-7722-5200 ext. 610, jude@medigen.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 60 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.