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
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（NeuMed-uPC）
The First Affiliated Hospital of Air Force Medicial University
3 participants
Jul 14, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn if Autologous Drug-Loaded Neutrophils (NeuMed) can treat patients with Unresectable Pancreatic Cancer. The drug carried by the Autologous Neutrophils is Monomethyl Auristatin E. The main questions it aims to answer are: First, to verify the safety of Autologous Drug-Loaded Neutrophils (NeuMed) in patients with Unresectable Pancreatic Cancer. Second, to assess the anti-tumor efficacy of Autologous Drug-Loaded Neutrophils (NeuMed) in patients with Unresectable Pancreatic Cancer.
Eligibility
Inclusion Criteria6
- 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 Criteria7
- 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
Interventions
Isolate the patients' autologous neutriphil cells, induce and culture them with Monomethyl Auristatin E (MMAE) in a GMP-compliant laboratory. Prior to the reinfusion of neutrophil biological agents into patients, stereotactic radiotherapy with a dose of 2-6 Gy is administered to pancreatic cancer lesions. The number of neutrophils that were reinfused was 2.0-8.0x10\^8.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07198659