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

Study Overview

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

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.

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).

Unresectable Pancreatic Cancer

COMBINATION_PRODUCT: Monomethyl Auristatin E (MMAE) / autologous neutrophil biological agents

KY20252120

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-08-15	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-09-26
First Submitted that Met QC Criteria 2025-09-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2025-09-30
First Posted (ESTIMATED) 2025-09-30	Results First Posted N/A	Last Verified 2025-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Monomethyl 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	COMBINATION_PRODUCT: Monomethyl 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Monomethyl 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

COMBINATION_PRODUCT: Monomethyl 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

Primary Outcome Measures	Measure Description	Time Frame
To verify the safety of Autologous Drug-Loaded Neutrophils (NeuMed) in patients with Unresectable Pancreatic Cancer	Incidence rate of Adverse Events（For the grading of treatment-related adverse events, all cases were classified with reference to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)）. Developed by the National Cancer Institute (NCI), the Common Terminology Criteria for Adverse Events (CTCAE) is currently the most widely used adverse event (AE) grading system, applicable to oncology clinical trials. It classifies adverse events into 5 grades:Grade 1 (Mild): Asymptomatic or mild in severity, with no requirement for intervention;Grade 2 (Moderate): Requiring medical intervention and causing mild impairment of daily activities;Grade 3 (Severe): Resulting in significant functional impairment, necessitating hospitalization or substantial medical intervention, and rendering the patient unable to perform daily activities;Grade 4 (Life-threatening): Pose a threat to life and require urgent intervention;Grade 5 (Death): Directly caused by the adverse event.	12 months

Secondary Outcome Measures	Measure Description	Time Frame
To assess the anti-tumor efficacy of Autologous Drug-Loaded Neutrophils (NeuMed) in patients with Unresectable Pancreatic Cancer	Objective Response Rate (ORR)；The ORR is determined by measuring the size of target and non-target tumor lesions in follow-up imaging data, in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST). The Response Evaluation Criteria in Solid Tumors (RECIST) classifies tumor response to treatment into distinct categories based on changes in the size of target lesions (and non-target lesions, as applicable) and the presence of new lesions, with the following specific grading framework:Complete Response (CR)；Partial Response (PR)；Stable Disease (SD)；Progressive Disease (PD). Imaging modalities for lesion measurement (e.g., contrast-enhanced CT, MRI) must be consistent throughout follow-up to ensure the reliability of SLD calculations, as mandated by the specific grading criteria in RECIST.	12 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Phone Number: 02984775260

Email: jinl2013@163.com

Study Contact Backup

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

Phone Number: 02984775260

Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Lin Wang, Doctor of Medicine(M.D.), The First Affiliated Hospital of Air Force Military Medical University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record