Status:
RECRUITING
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
Lead Sponsor:
The First Affiliated Hospital of Air Force Medicial University
Conditions:
Unresectable Pancreatic Cancer
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
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 Mon...
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. Neutroph...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 14 2027
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT07198659
Start Date
July 14 2025
End Date
July 14 2027
Last Update
September 30 2025
Active Locations (1)
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1
The First Affiliated Hospital of the PLA Air Force Military Medical University
Xi’an, Shanxi, China, 710000