Actively Recruiting
Phase I/II Study: Allogeneic NK-cell Therapy With Chemotherapy for Post-Surgery PDA or Cholangiocarcinoma Patients
Led by Medigen Biotechnology Corporation · Updated on 2025-12-17
42
Participants Needed
1
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase I/II Study: Allogeneic NK-cell Therapy With Chemotherapy for Post-Surgery PDA or Cholangiocarcinoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- Adults aged 18 years or older at the time of consent.
- Macroscopic resection of primary tumor with stage II or III disease before or at surgery.
- Residual tumor classified as R0 or R1.
- Negative cytologic examination from intraoperative peritoneal lavage.
- Histologically confirmed pancreatic ductal adenocarcinoma or cholangiocarcinoma.
- Curative resection within 12 weeks before screening and planned adjuvant SLOG chemotherapy.
- ECOG performance status of 0 or 1.
- Adequate blood counts: WBC ≥ 3,000 cells/mm3, ANC ≥ 1,500 cells/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL, INR normal.
- Adequate liver and kidney function with serum creatinine ≤ 1.5 x ULN, BUN ≤ 1.5 x ULN, total bilirubin ≤ 1.5 x ULN, ALT and AST ≤ 2.5 x ULN, ALP ≤ 5 x ULN, albumin ≥ 3.0 g/dL.
- Negative for HIV and syphilis (RPR/VDRL and TPHA).
- Positive for past cytomegalovirus (CMV) infection (CMV IgG positive).
- Women and men with childbearing potential agree to use at least two contraceptive methods, including a barrier method, from consent until specified periods post-treatment.
- Agree to comply with clinical protocol treatments.
You will not qualify if you...
- Received other investigational or immune cell therapies, or anti-cancer drugs within 28 days before screening.
- History of malignant tumors except certain treated non-invasive skin cancers or other cancers disease-free for more than 5 years.
- Immunocompromised or on immunosuppressive treatment for autoimmune disease or systemic steroids >30 mg/day prednisolone equivalent for more than 7 days within 14 days before Day 1.
- Known metastatic disease.
- Serious medical conditions in the past 2 years that could interfere with the trial or safety.
- Hypercoagulable state prone to thrombosis.
- Known allergies to aminoglycosides, bacitracin, or components of the investigational or chemotherapy drugs.
- Contraindications to S-1, leucovorin, oxaliplatin, or gemcitabine, including severe myelosuppression.
- Symptomatic cytomegalovirus disease.
- History or suspicion of cardiac arrhythmia or prolonged QT interval.
- QTc ≥ 450 ms for males or ≥ 470 ms for females.
- Use of drugs that prolong QT interval within 28 days before screening.
- Use of brivudine, analogs, or live vaccines within 28 days before screening.
- Female subjects who are breastfeeding or pregnant at screening.
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Cheng Kung University Hospital
Tainan, Taiwan, 138
Actively Recruiting
Research Team
J
Jude Chen
CONTACT
D
Doris Huang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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