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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital of Air Force Medicial University

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Monomethyl Auristatin E (MMAE) / autologous neutrophil biological agents

Treatment groups

3 Participants
are divided into 1 treatment group