A Single-Arm Investigator-Initiated Tria (IIT) Evaluating the Safety and Preliminary Efficacy of Autologous Drug-Loaded Neutrophils (NeuMed) in Patients With Unresectable Pancreatic Cancer

In this open, single-armed study, selected patients with Unresectable Pancreatic Cancer confirmed by Histopathology will be received Autologous Drug-Loaded Neutrophils (NeuMed)-based therapy. Neutrophils will be isolated using a blood cell separator and cultured in a GMP-compliant laboratory to prepare neutrophil biological agents, which will then be loaded with the anti-tumor peptide, Monomethyl Auristatin E (MMAE).

Inclusion criteria

• 18-70 years
• Obtain an informed consent form voluntarily signed by the patient themselves
• patients with Unresectable Pancreatic Cancer confirmed by Histopathology
• Patients who either: 1) have received standard first-line treatments, proven ineffective or causing intolerable adverse effects; or 2) have not received the standard first-line treatments and voluntarily opt for Autologous Drug-Loaded Neutrophils (NeuMed)-based therapy
• EOCG score ≤ 2 and expected survival time ≥ 3 months
• Liver, kidney and bone marrow functions are basically normal

Exclusion criteria

• Patients who required anti coagulant therapy
• Patients with active infectious diseases or a history of bone marrow or organ transplantation
• Patients with autoimmune diseases or autoinflammatory diseases
• Patients with a history of severe cardiovascular or cerebrovascular diseases or interstitial lung disease or non-infectious pneumonia
• Patients who have received live vaccines within 30 days prior to enrollment
• Patients with no response to bone marrow mobilization
• Other patients deemed unsuitable for enrollment by the investigator