Pancreatic Carcinoma Stage IIPhase 1/2NCT06730009
Phase I/II Study: Allogeneic NK-cell Therapy With Chemotherapy for Post-Surgery PDA or Cholangiocarcinoma Patients
A Phase 1/2 study testing SLOG + Allogeneic NK cell and SLOG chemotherapy in people with Pancreatic Carcinoma Stage II and Cholangiocarcinoma Resectable, run by Medigen Biotechnology Corporation at 1 site in Taiwan.
Trial summary
This is a phase I/II study which intends to characterize the safety, tolerability, and preliminary efficacy of Allogeneic Magicell-NK infusion in PDA or cholangiocarcinoma patients after surgery. Subjects will receive a total of 6 intravenous (IV) infusions of the IP on the 11th day of each chemotherapy cycle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Carcinoma Stage II, Cholangiocarcinoma Resectable
- What is being tested?
- SLOG + Allogeneic NK cell and SLOG chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Oct 2024to 31 Aug 2029
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dated and signed informed consent.
- Either sex, aged older than 18 years old (inclusive) at date of consent.
- Subject with a macroscopic resection of the primary tumor and residual primary tumor that satisfies all of the items below according to the Union for International Cancer Control (UICC) histopathologic staging system:
- At or before the surgery, stage II or stage III.
- Local residual tumor classified as R0 or R1.
- Cytologic examination negative upon intraoperative peritoneal lavage.
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- Histologically confirmed PDA or cholangiocarcinoma.
- Received curative resection within 12 weeks prior to screening visit and will receive adjuvant SLOG chemotherapy. Note: Subjects with cancer who had undergone surgery with or without prior neo-adjuvant therapy will be recruited.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
- Subject with adequate hematology function at Visit 1:
- Total white blood cell (WBC) ≥ 3,000 cells/mm3.
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3.
- Platelets ≥ 100,000 counts/mm3.
- Hemoglobin ≥ 9 g/dL.
- International normalized ratio (INR) of prothrombin time within normal range. Note: Re-test for eligibility is allowed during the screening period.
- Subject with adequate hepatic and renal function at Visit 1:
- Serum creatinine ≤ 1.5× Upper Limit of Normal (ULN).
- Blood urea nitrogen (BUN) ≤ 1.5× ULN.
- Total bilirubin ≤ 1.5× ULN.
- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5× ULN.
- Alkaline phosphatase (ALP) ≤ 5× ULN.
- Albumin ≥ 3.0 g/dL. Note: Re-test for eligibility is allowed during the screening period.
- Negative response in human immunodeficiency virus (HIV) and treponema pallidum (rapid plasma reagin [RPR]/venereal disease research laboratory [VDRL] and treponema pallidum hemagglutination [TPHA]).
- Subject confirmed with past cytomegalovirus (CMV) infection in terms of having positive CMV immunoglobin G (CMV IgG).
- Subject with childbearing potential must agree to use at least two contraceptive precautions, one of which must be a condom or other adequate barrier method, from
- signing informed consent until 28 days after the last dose of investigational product (IP) administration.
- initiation of oxaliplatin treatment until at least 15 months (female) or 12 months (male) following the last dose.
- initiation of gemcitabine treatment until at least 6 months (female) or 3 months (male) following the last dose.
- Agree to be in compliance with clinical protocol-planned treatment. Note: Anti-virus treatment is allowed if active hepatitis B is presented.
Who cannot join
- Received any other investigational, anti-neoplastic medications, or immune cell therapy within 28 days prior to screening visit.
- Any prior history of malignant neoplasm, except:
- Non-invasive, non-melanomatous skin cancer (including squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ), curatively treated with cryosurgery or surgical excision only.
- Other primary malignant neoplasm diagnosed as disease free for more than 5 years.
- Immunocompromized, currently under immunosuppressive treatment for autoimmune disease, or have received systemic steroid of equivalent dosage higher than prednisolone 30 mg/day for more than 7 days within 14 days prior to Day 1.
- With known metastases.
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- With ongoing acute diseases, or serious medical conditions within the past 2 years prior to screening, 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 in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the subject.
- Hypercoagulable state that may lead to clinically apparent thrombosis.
- With known hypersensitivity to aminoglycoside (e.g., streptomycin, gentamicin) or bacitracin.
- With known hypersensitivity to any of the components of Allogeneic Magicell-NK, including human serum albumin.
- With known hypersensitivity to any of the components of S-1, leucovorin, oxaliplatin, or gemcitabine.
- With any contraindication to S-1, leucovorin, oxaliplatin, or gemcitabine, including:
- Severe myelosuppression or myelosuppression that probably exacerbates.
- With symptomatic CMV disease.
- With any history of diagnosed or suspected cardiac arrhythmia or QT interval prolongation.
- Male subject with a corrected QT interval (QTc) ≥ 450 ms and female subject with a QTc ≥ 470 ms as determined by electrocardiogram (ECG) examination at screening.
- Received any drugs associated with QT prolongation within 28 days prior to the Screening Visit (refer to Appendix 3. Drugs Associated with QT Prolongation, including but not limited to the drug listed therein).
- Received brivudine or its analogs (e.g., sorivudine) or any live vaccines within 28 days prior to the Screening Visit.
- Female subject who is lactating or has positive serum or 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
National Cheng Kung University Hospital
Tainan, 138
Yan Shen Shan, MD, PhD, 886-6-2353535 ext. 3116, ysshan@mail.ncku.edu.tw
Yan Shen Shan, MD, PhD
About this study
Official title: A Dose-Finding Phase I Followed by a Phase II Study to Evaluate the Safety and Efficacy of Allogeneic NK-cell Combined With Chemotherapy in Patients With PDA or Cholangiocarcinoma After Surgery
This is a phase I/II study which intends to characterize the safety, tolerability, and preliminary efficacy of Allogeneic Magicell-NK infusion in PDA or cholangiocarcinoma patients after surgery. Subjects will receive a total of 6 intravenous (IV) infusions of the IP on the 11th day of each chemotherapy cycle. A total of 6 cycles of IP infusions are planned.
The phase I part of the study is a first-in-human phase I trial of Allogeneic Magicell-NK and is therefore designed in an open-label, dose-escalation manner. A standard 3+3 design will be employed to assess the safety profile of Allogeneic Magicell-NK and to determine the MTD/MFD. Two dose cohorts are planned: the starting dose is 10 × 10^8 cells (Cohort 1), and escalates to 20 × 10^8 cells (Cohort 2).
The phase II part of the study is designed as an open-label, two-arm, randomized clinical trial comparing the combination of SLOG and Allogeneic Magicell-NK with SLOG alone when used as adjuvant therapy following resection for PDA or Cholangiocarcinoma. Approximately 30 subjects will be randomized at a 2:1 ratio between the two arms: Arm 1: SLOG and Allogeneic Magicell-NK (20 subjects); Arm 2: SLOG alone (10 subjects). Subjects will then receive 12 weeks of SLOG chemotherapy with or without Allogeneic Magicell-NK infusion.
- Being tested
- SLOG + Allogeneic NK cell, SLOG chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLOG + Allogeneic NK cellBiological
Drug: SLOG chemotherapy S-1, leucovorin, oxaliplatin, and gemcitabine (SLOG)
Biological:
Allogeneic Magicell-NK contains NK cells suspended in 100 mL of normal saline Ph I dose starts at 10 × 10^8 cells (Cohort 1) and escalates to 20 × 10^8 cells (Cohort 2).
Ph II dose will be determined lower than or equal to Ph I MTD/MFD.
SLOG chemotherapyDrug
Drug: SLOG chemotherapy S-1, leucovorin, oxaliplatin, and gemcitabine (SLOG)
| Study group | Role | What they receive |
|---|---|---|
| SLOG + Allogeneic NK cells | Experimental | Ph I SLOG + Allogeneic NK cell dose escalation (Cohort 1:10 × 10^8 cells ; Cohort 2:20 × 10^8 cells) Ph II Arm 1 SLOG + Allogeneic NK cell Receives: Biological: SLOG + Allogeneic NK cell |
| SLOG chemotherapy | Active comparator | Ph II Arm 2 Receives: Drug: SLOG chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ph I Evaluation of safety parameters, numbers of participants with Treatment-Emergent Adverse Events (TEAEs).
The number of participants with Treatment-Emergent Adverse Events (TEAEs) was assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) to assess the tolerability of Magicell-NK treatment.
Measured: 15 months
Ph I Laboratory tests
Number of participants with abnormal laboratory test results.
Measured: 15 months
Ph I Body weight
Body weight (KG) will be measured at baseline, treatment, and F1 visits. The number of participants with abnormal body weight change.
Measured: 5 months
Ph I Vital signs
Number of participants with abnormal vital signs.
Measured: 15 months
Ph I Dose-limiting toxicities
Adverse events were assessed according to NCI-CTCAE v5.0 criteria.
Measured: 4 months
Ph I Maximum Tolerated Dose (MTD) and Recommended Phase II Dose
MTD is defined as the highest dose level at which ≤ 1/6 of subjects experienced DLT.
Measured: 4 months
Ph II 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 PDA or Cholangiocarcinoma, or death from any cause).
Measured: 15 months
Secondary outcomes (9)
Ph I 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 PDA or Cholangiocarcinoma, or death from any cause)
Measured: 15 months
Ph II Evaluation of safety parameters, numbers of participants with Treatment-Emergent Adverse Events (TEAEs)
The number of participants with Treatment-Emergent Adverse Events (TEAEs) was assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) to assess the tolerability of Magicell-NK treatment.
Measured: 15 months
Ph II Laboratory tests
Number of participants with abnormal laboratory test results.
Measured: 15 months
Ph II Body weight
Body weight (KG) will be measured at baseline, treatment, and F1 visits. The number of participants with abnormal body weight change.
Measured: 5 months
Ph II Vital signs
Number of participants with abnormal vital signs.
Measured: 15 months
Ph I/II Tumor recurrence rate (TRR)
To evaluate the Tumor recurrence rate (TRR) during the study period
Measured: 15 months
Ph I/II Changes in Frequency and Duration of ctDNA
Number of participants experiencing ctDNA seroconversion (i.e. ctDNA+ that become ctDNA-) after any Allogeneic Magicell-NK regimen remaining disease free
Measured: Up to 15 months
Ph I/II Changes in Frequency and Duration of Circulating Tumor Count (CTC)
Determine the effect of Allogeneic Magicell-NK on reducing CTC of whole blood in the subject with elevated baseline CTC count to identify the least effective dose that clears CTCs. The baseline count of CTC will be recorded before Allogeneic Magicell-NK therapy in a whole blood sample. In the treatment, the count of CTC will be measured at C4D1 and each follow-up visit after Allogeneic Magicell-NK therapy in a whole blood sample. All of these values will be compared.
Measured: Up to 15 months
Ph I/II Changes in Biomarkers (CA19-9 and CEA)
Determine the effect of Allogeneic Magicell-NK on CEA and CA 19-9 in the subject with elevated baseline CEA and CA 19-9 to identify the least effective dose that clears CEA and CA 19-9. The baseline count of CEA and CA 19-9 will be recorded before Allogeneic Magicell-NK therapy. In the treatment, the count of CEA and CA 19-9 will be measured at C4D1. And each follow-up visit after Allogeneic Magicell-NK therapy. All of these values will be compared.
Measured: Up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start21 Oct 2024
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Carcinoma Stage IIStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 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
- NCT06730009
- Sponsor's protocol ID
- CT-ANK-21
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2024
- Last updated
- 17 Dec 2025
- 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 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Finding Phase I Followed by a Phase II Study to Evaluate the Safety and Efficacy of Allogeneic NK-cell Combined With Chemotherapy in Patients With PDA or Cholangiocarcinoma After Surgery
- ClinicalTrials.gov ID
- NCT06730009
- Acronym / sponsor ID
- CT-ANK-21
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Medigen Biotechnology CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 12 Dec 2024 (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/II study which intends to characterize the safety, tolerability, and preliminary efficacy of Allogeneic Magicell-NK infusion in PDA or cholangiocarcinoma patients after surgery. Subjects will receive a total of 6 intravenous (IV) infusions of the IP on the 11th day of each chemotherapy cycle. A total of 6 cycles of IP infusions are planned.
The phase I part of the study is a first-in-human phase I trial of Allogeneic Magicell-NK and is therefore designed in an open-label, dose-escalation manner. A standard 3+3 design will be employed to assess the safety profile of Allogeneic Magicell-NK and to determine the MTD/MFD. Two dose cohorts are planned: the starting dose is 10 × 10^8 cells (Cohort 1), and escalates to 20 × 10^8 cells (Cohort 2).
The phase II part of the study is designed as an open-label, two-arm, randomized clinical trial comparing the combination of SLOG and Allogeneic Magicell-NK with SLOG alone when used as adjuvant therapy following resection for PDA or Cholangiocarcinoma. Approximately 30 subjects will be randomized at a 2:1 ratio between the two arms: Arm 1: SLOG and Allogeneic Magicell-NK (20 subjects); Arm 2: SLOG alone (10 subjects). Subjects will then receive 12 weeks of SLOG chemotherapy with or without Allogeneic Magicell-NK infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLOG + Allogeneic NK cells | Experimental | Biological: SLOG + Allogeneic NK cellPh I SLOG + Allogeneic NK cell dose escalation (Cohort 1:10 × 10^8 cells ; Cohort 2:20 × 10^8 cells) Ph II Arm 1 SLOG + Allogeneic NK cell |
| SLOG chemotherapy | Active comparator | Drug: SLOG chemotherapyPh II Arm 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Dated and signed informed consent.
- Either sex, aged older than 18 years old (inclusive) at date of consent.
- Subject with a macroscopic resection of the primary tumor and residual primary tumor that satisfies all of the items below according to the Union for International Cancer Control (UICC) histopathologic staging system:
- Histologically confirmed PDA or cholangiocarcinoma.
- Received curative resection within 12 weeks prior to screening visit and will receive adjuvant SLOG chemotherapy. Note: Subjects with cancer who had undergone surgery with or without prior neo-adjuvant therapy will be recruited.
Key exclusion criteria (19 listed)
- Received any other investigational, anti-neoplastic medications, or immune cell therapy within 28 days prior to screening visit.
- Any prior history of malignant neoplasm, except:
- Immunocompromized, currently under immunosuppressive treatment for autoimmune disease, or have received systemic steroid of equivalent dosage higher than prednisolone 30 mg/day for more than 7 days within 14 days prior to Day 1.
- With known metastases.
- With ongoing acute diseases, or serious medical conditions within the past 2 years prior to screening, 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 in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the subject.
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 |
|---|---|---|
| SLOG + Allogeneic NK cellDrug: SLOG chemotherapy S-1, leucovorin, oxaliplatin, and gemcitabine (SLOG) Biological: Allogeneic Magicell-NK contains NK cells suspended in 100 mL of normal saline Ph I dose starts at 10 × 10^8 cells (Cohort 1) and escalates to 20 × 10^8 cells (Cohort 2). Ph II dose will be determined lower than or equal to Ph I MTD/MFD. | Biological | SLOG + Allogeneic NK cells |
| SLOG chemotherapyDrug: SLOG chemotherapy S-1, leucovorin, oxaliplatin, and gemcitabine (SLOG) | Drug | SLOG chemotherapy |
Primary outcome
Ph I Evaluation of safety parameters, numbers of participants with Treatment-Emergent Adverse Events (TEAEs).
Time frame: 15 months
The number of participants with Treatment-Emergent Adverse Events (TEAEs) was assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) to assess the tolerability of Magicell-NK treatment.
Ph I Laboratory tests
Time frame: 15 months
Number of participants with abnormal laboratory test results.
Ph I Body weight
Time frame: 5 months
Body weight (KG) will be measured at baseline, treatment, and F1 visits. The number of participants with abnormal body weight change.
Ph I Vital signs
Time frame: 15 months
Number of participants with abnormal vital signs.
Ph I Dose-limiting toxicities
Time frame: 4 months
Adverse events were assessed according to NCI-CTCAE v5.0 criteria.
Ph I Maximum Tolerated Dose (MTD) and Recommended Phase II Dose
Time frame: 4 months
MTD is defined as the highest dose level at which ≤ 1/6 of subjects experienced DLT.
Ph II Disease-free survival (DFS)
Time frame: 15 months
The time from the date of the first Magicell-NK infusion to the date of the first disease-free survival event (recurrence, second primary PDA or Cholangiocarcinoma, or death from any cause).
9 secondary outcomes
Ph I Disease-free survival (DFS)
Time frame: 15 months
Ph II Evaluation of safety parameters, numbers of participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: 15 months
Ph II Laboratory tests
Time frame: 15 months
Ph II Body weight
Time frame: 5 months
Ph II Vital signs
Time frame: 15 months
Ph I/II Tumor recurrence rate (TRR)
Time frame: 15 months
Ph I/II Changes in Frequency and Duration of ctDNA
Time frame: Up to 15 months
Ph I/II Changes in Frequency and Duration of Circulating Tumor Count (CTC)
Time frame: Up to 15 months
Ph I/II Changes in Biomarkers (CA19-9 and CEA)
Time frame: Up to 15 months
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 17 Dec 2025.
- 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 1/2 study testing SLOG + Allogeneic NK cell and SLOG chemotherapy in people with Pancreatic Carcinoma Stage II and Cholangiocarcinoma Resectable, 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 29 inclusion and 19 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 17 Dec 2025. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 (886-2-77225200 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?
Ph I Evaluation of safety parameters, numbers of participants with Treatment-Emergent Adverse Events (TEAEs). (time frame: 15 months). The study lists 7 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 17 Dec 2025.