RecruitingEarly Phase 1NCT07198659

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)


Sponsor

The First Affiliated Hospital of Air Force Medicial University

Enrollment

3 participants

Start Date

Jul 14, 2025

Study Type

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of treatment for unresectable pancreatic cancer using the patient's own white blood cells (neutrophils) that have been loaded with anti-cancer drugs. These cells are then reinfused into the patient, where they may deliver the drug directly to the tumor. **You may be eligible if...** - You are 18–70 years old - You have been confirmed to have pancreatic cancer that cannot be removed with surgery - You have either already tried standard treatments that haven't worked, or you are choosing this new therapy voluntarily - You are in reasonable health (ECOG ≤ 2) with an expected survival of at least 3 months - Your liver, kidney, and blood counts are adequate **You may NOT be eligible if...** - You require blood-thinning (anticoagulant) therapy - You have an active infection, or a history of bone marrow or organ transplantation - You have an autoimmune or auto-inflammatory disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTMonomethyl Auristatin E (MMAE) / autologous neutrophil biological agents

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)

The First Affiliated Hospital of the PLA Air Force Military Medical University

Xi’an, Shanxi, China

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NCT07198659


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