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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Phase I/II Study: Allogeneic NK-cell Therapy With Chemotherapy for Post-Surgery PDA or Cholangiocarcinoma Patients

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

Phase I/II Study: Allogeneic NK-cell Therapy With Chemotherapy for Post-Surgery PDA or Cholangiocarcinoma Patients (NCT06730009) is a Phase 1 / Phase 2 interventional studying Pancreatic Carcinoma Stage II and Cholangiocarcinoma Resectable, sponsored by Medigen Biotechnology Corporation. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Pancreatic Carcinoma Stage II, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 42 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Dated and signed willing to sign a consent form. 2. Either sex, aged older than 18 years old (inclusive) at date of consent. 3. 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. 4. diagnosed by tissue sample (biopsy-confirmed) PDA or cholangiocarcinoma. 5. 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. 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. 7. 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. - platelet count at least 100,000 counts/mm3. - blood count (hemoglobin) at least 9 g/dL. - International normalized ratio (INR) of prothrombin time within normal range. Note: Re-test for eligibility is allowed during the screening period. 8. 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. 9. Negative response in human weakened immune system virus (HIV) and treponema pallidum (rapid plasma reagin \[RPR\]/venereal disease research laboratory \[VDRL\] and treponema pallidum hemagglutination \[TPHA\]). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Dated and signed informed consent. 2. Either sex, aged older than 18 years old (inclusive) at date of consent. 3. 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. 4. Histologically confirmed PDA or cholangiocarcinoma. 5. 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. 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. 7. 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. 8. 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. 9. Negative response in human immunodeficiency virus (HIV) and treponema pallidum (rapid plasma reagin \[RPR\]/venereal disease research laboratory \[VDRL\] and treponema pallidum hemagglutination \[TPHA\]). 10. Subject confirmed with past cytomegalovirus (CMV) infection in terms of having positive CMV immunoglobin G (CMV IgG). 11. 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. 12. Agree to be in compliance with clinical protocol-planned treatment. Note: Anti-virus treatment is allowed if active hepatitis B is presented. Exclusion Criteria: 1. Received any other investigational, anti-neoplastic medications, or immune cell therapy within 28 days prior to screening visit. 2. Any prior history of malignant neoplasm, except: 1. 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. 2. Other primary malignant neoplasm diagnosed as disease free for more than 5 years. 3. 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. 4. With known metastases. 5. 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. 6. Hypercoagulable state that may lead to clinically apparent thrombosis. 7. With known hypersensitivity to aminoglycoside (e.g., streptomycin, gentamicin) or bacitracin. 8. With known hypersensitivity to any of the components of Allogeneic Magicell-NK, including human serum albumin. 9. With known hypersensitivity to any of the components of S-1, leucovorin, oxaliplatin, or gemcitabine. 10. With any contraindication to S-1, leucovorin, oxaliplatin, or gemcitabine, including: \- Severe myelosuppression or myelosuppression that probably exacerbates. 11. With symptomatic CMV disease. 12. With any history of diagnosed or suspected cardiac arrhythmia or QT interval prolongation. 13. 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. 14. 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). 15. Received brivudine or its analogs (e.g., sorivudine) or any live vaccines within 28 days prior to the Screening Visit. 16. Female subject who is lactating or has positive serum or urine pregnancy test at screening.

Treatments Being Tested

BIOLOGICAL

SLOG + Allogeneic NK cell

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.

DRUG

SLOG chemotherapy

Drug: SLOG chemotherapy S-1, leucovorin, oxaliplatin, and gemcitabine (SLOG)

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

National Cheng Kung University Hospital
Tainan, Taiwan

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06730009), the sponsor (Medigen Biotechnology Corporation), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06730009 clinical trial studying?

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 Allogenei… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06730009?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06730009?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06730009. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06730009. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.