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.
Dated and signed informed consent.
Either sex, aged older than 18 years old (inclusive) at date of consent.
At or before the surgery, stage II or stage III.
Local residual tumor classified as R0 or R1.
Received any other investigational, anti-neoplastic medications, or immune cell therapy within 28 days prior to screening visit.
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.
Sequential
SLOG + Allogeneic NK cell
Biological/VaccineDrug: 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 chemotherapy
DrugDrug: SLOG chemotherapy S-1, leucovorin, oxaliplatin, and gemcitabine (SLOG)
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.
Ph I Laboratory tests
Number of participants with abnormal laboratory test results.
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.
Ph I Vital signs
Number of participants with abnormal vital signs.
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)
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.
Ph II Laboratory tests
Number of participants with abnormal laboratory test results.
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.
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