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

NCT06730009 | Recruiting Phase 1 DMC

• 1 other identifier: CT-ANK-21
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cholangiocarcinoma Resectable; Pancreatic Carcinoma Stage II

Outcome Measures

Primary Outcomes (7)

• 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.

  15 months

• Ph I Laboratory tests

  Number of participants with abnormal laboratory test results.

  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.

  5 months

• Ph I Vital signs

  Number of participants with abnormal vital signs.

  15 months

• Ph I Dose-limiting toxicities

  Adverse events were assessed according to NCI-CTCAE v5.0 criteria.

  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.

  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).

  15 months

Secondary Outcomes (9)

• Ph I Disease-free survival (DFS)

  15 months

• Ph II Evaluation of safety parameters, numbers of participants with Treatment-Emergent Adverse Events (TEAEs)

  15 months

• Ph II Laboratory tests

  15 months

• Ph II Body weight

  5 months

• Ph II Vital signs

  15 months

Study Arms (2)

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

Biological: SLOG + Allogeneic NK cell

SLOG chemotherapy

ACTIVE COMPARATOR

Ph II Arm 2

Drug: SLOG chemotherapy

Interventions

SLOG chemotherapy DRUG

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

SLOG chemotherapy

SLOG + Allogeneic NK cell BIOLOGICAL

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 + Allogeneic NK cells

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medigen Biotechnology Corporation: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 138, Taiwan

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Stanley Chang, PhD

  Medigen Biotechnology Corporation

  STUDY CHAIR

Central Study Contacts

Jude Chen

CONTACT

886-2-77225200; jude@medigen.com.tw

Doris Huang

CONTACT

886-2-77225200; doris.huang@medigen.com.tw

Study Design

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

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 12, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)