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

NCT06730009 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-12-17

No results posted yet for this study

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

  • Pancreatic Carcinoma Stage II
  • Cholangiocarcinoma Resectable

Interventions

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)

Sponsors & Collaborators

  • Medigen Biotechnology Corporation

    lead INDUSTRY

Principal Investigators

  • Stanley Chang, PhD · Medigen Biotechnology Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2029-01-31
Completion
2029-08-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06730009 on ClinicalTrials.gov