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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

NCT07198659 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-09-30

No results posted yet for this study

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

Interventions

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 of 2-6 Gy is administered to pancreatic cancer lesions. The number of neutrophils that were reinfused was 2.0-8.0x10\^8.

Sponsors & Collaborators

  • The First Affiliated Hospital of Air Force Medicial University

    lead OTHER

Principal Investigators

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

  • Liang Jin, Doctor of Medicine(M.D.) · The First Affiliated Hospital of Air Force Military Medical University

  • Yong Chen, Doctor of Medicine(M.D.) · The First Affiliated Hospital of Air Force Military Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-14
Primary Completion
2027-07-14
Completion
2027-07-14

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07198659 on ClinicalTrials.gov