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

Recruiting now · Early Phase 1

Conditions studied: Unresectable Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT07198659

Run by

The First Affiliated Hospital of Air Force Medicial University

People needed

3

Starts

2025-07-14

Expected to finish

2027-07-14

Last updated by the study team

2025-09-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The First Affiliated Hospital of the PLA Air Force Military Medical University — Xi’an, Shanxi, China (enrolling)

Full record on ClinicalTrials.gov

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