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Clinical Trial Record

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

2024-10-21

2029-01-31

2029-08-31

42

Study Overview

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

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.

N/A

  • Pancreatic Carcinoma Stage II
  • Cholangiocarcinoma Resectable
  • BIOLOGICAL: SLOG + Allogeneic NK cell
  • DRUG: SLOG chemotherapy
  • CT-ANK-21

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2024-12-02  

N/A  

2024-12-09  

2024-12-09  

N/A  

2024-12-12  

2024-12-12  

N/A  

2024-10  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: SLOG + Allogeneic NK cells

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

  • 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 (Cohor
ACTIVE_COMPARATOR: SLOG chemotherapy

Ph II Arm 2

DRUG: SLOG chemotherapy

  • Drug: SLOG chemotherapy S-1, leucovorin, oxaliplatin, and gemcitabine (SLOG)
Primary Outcome MeasuresMeasure DescriptionTime Frame
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 testsNumber of participants with abnormal laboratory test results.15 months
Ph I Body weightBody 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 signsNumber of participants with abnormal vital signs.15 months
Ph I Dose-limiting toxicitiesAdverse events were assessed according to NCI-CTCAE v5.0 criteria.4 months
Ph I Maximum Tolerated Dose (MTD) and Recommended Phase II DoseMTD 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 Outcome MeasuresMeasure DescriptionTime Frame
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)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.15 months
Ph II Laboratory testsNumber of participants with abnormal laboratory test results.15 months
Ph II Body weightBody weight (KG) will be measured at baseline, treatment, and F1 visits. The number of participants with abnormal body weight change.5 months
Ph II Vital signsNumber of participants with abnormal vital signs.15 months
Ph I/II Tumor recurrence rate (TRR)To evaluate the Tumor recurrence rate (TRR) during the study period15 months
Ph I/II Changes in Frequency and Duration of ctDNANumber of participants experiencing ctDNA seroconversion (i.e. ctDNA+ that become ctDNA-) after any Allogeneic Magicell-NK regimen remaining disease freeUp 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.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.Up to 15 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jude Chen

Phone Number: 886-2-77361234

Email: jude@medigen.com.tw

Study Contact Backup

Name: Doris Huang

Phone Number: 886-2-77361234

Email: doris.huang@medigen.com.tw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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 where resection included the celiac artery
  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • STUDY_CHAIR: Stanley Chang, PhD, Medigen Biotechnology Corporation

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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