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 | Recruiting Early Phase 1 DMC

• 1 other identifier: KY20252120
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unresectable Pancreatic Cancer

Keywords

Autologous Drug-Loaded Neutrophils (NeuMed); Unresectable Pancreatic Cancer; Monomethyl Auristatin E (MMAE)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To assess the anti-tumor efficacy of Autologous Drug-Loaded Neutrophils (NeuMed) in patients with Unresectable Pancreatic Cancer

  12 months

Study Arms (1)

Monomethyl Auristatin E (MMAE) / autologous neutrophil biological agents

EXPERIMENTAL

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.

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

Interventions

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

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.

Monomethyl Auristatin E (MMAE) / autologous neutrophil biological agents

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Air Force Medicial University: lead

Study Sites (1)

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

Xi’an, Shanxi, 710000, China

RECRUITING

MeSH Terms

Interventions

monomethyl auristatin E

Study Officials

• Lin Wang, Doctor of Medicine(M.D.)

  The First Affiliated Hospital of Air Force Military Medical University

  STUDY DIRECTOR

• Liang Jin, Doctor of Medicine(M.D.)

  The First Affiliated Hospital of Air Force Military Medical University

  PRINCIPAL INVESTIGATOR

• Yong Chen, Doctor of Medicine(M.D.)

  The First Affiliated Hospital of Air Force Military Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

02984775260; jinl2013@163.com

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

CONTACT

02984775260

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: September 30, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): July 14, 2027
• Study Completion (Estimated): July 14, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)