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 Allogenei

Trial Details

NCT ID
NCT06730009
Phase
PHASE1 / PHASE2
Sponsor
Medigen Biotechnology Corporation
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • SLOG + Allogeneic NK cell
  • SLOG chemotherapy
Locations (sample)
  • Tainan, Taiwan|22.99083,120.21333

Key Eligibility Criteria

  • 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 f…
  • At or before the surgery, stage II or stage III.

For full eligibility, visit ClinicalTrials.gov.

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