Medigen’s proprietary allogeneic natural killer (NK) cell therapy platform, Magicell-NK, has successfully initiated a Phase I/II clinical trial at National Cheng Kung University Hospital for the adjuvant treatment of patients with pancreatic ductal adenocarcinoma (PDAC) or cholangiocarcinoma following curative surgery in combination with chemotherapy. The trial achieved First Patient In (FPI) on June 29, 2026 and is expected to enroll up to 42 patients.
PDAC and cholangiocarcinoma are highly aggressive malignancies with substantial postoperative recurrence rates, even after curative surgical resection. According to a 2023 study, the overall recurrence rate of PDAC reaches approximately 60% to 80% within five years after surgery, while 25% to 38% of patients experience recurrence within the first six months. These findings highlight the significant risk of disease recurrence despite standard treatment. Current options for postoperative adjuvant therapy remain limited, underscoring the urgent need for novel therapeutic approaches to reduce recurrence and improve patient survival.
A key innovation of this clinical trial is the use of Medigen’s proprietary allogeneic Magicell-NK technology. The NK cells are derived from peripheral blood donated by healthy donors and do not require human leukocyte antigen (HLA) matching. Following ex vivo expansion, the NK cells are infused into patients. This treatment approach is designed to provide a flexible and available cell therapy without interfering with patients' ongoing treatment regimens.
Our pipeline is built on the concept of controlling Minimal Residual Disease (MRD) after surgery to reduce the risk of cancer recurrence. We are focusing on Magicell-NK cell therapies for cancers with high unmet medical needs, including colorectal cancer, pancreatic ductal adenocarcinoma (PDAC), and cholangiocarcinoma. Two Magicell-NK products—autologous Magicell-NK and allogeneic Magicell-NK—have been approved by the Taiwan Food and Drug Administration (TFDA) to conduct Phase I clinical trials.
If allogeneic Magicell-NK demonstrates favorable safety and promising preliminary efficacy in this clinical trial, , it could be developed as an adjuvant therapy in combination with chemotherapy for patients with PDAC and cholangiocarcinoma after curative surgery. In addition, this would represent a significant milestone for Medigen’s Magicell-NK technology in advancing the application of allogeneic cell therapy.