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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 | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

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

NCT07198659•The First Affiliated Hospital of Air Force Medicial University

View on ClinicalTrials.gov

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.

Detailed Description

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).

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

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

Xi’an, Shanxi, China

Key Dates

Start Date

July 14, 2025

Primary Completion Date

July 14, 2027

Completion Date

July 14, 2027

Last Updated

September 30, 2025

Enrollment

ESTIMATED participants

Conditions

Unresectable Pancreatic Cancer

Interventions

Monomethyl Auristatin E (MMAE) / autologous neutrophil biological agents

COMBINATION_PRODUCT

Contacts

Liang Jin, Doctor of Medicine(M.D.)

CONTACT

02984775260 jinl2013@163.com

Lin Wang, Doctor of Medicine(M.D.)

CONTACT

02984775260

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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