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
Recruiting · NCT07198659 · Interventional (participants receive a specific treatment) · Lead sponsor: The First Affiliated Hospital of Air Force Medicial University
View the official record on ClinicalTrials.gov →Interventions studied
Monomethyl Auristatin E (MMAE) / autologous neutrophil biological agents
What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- The First Affiliated Hospital of the PLA Air Force Military Medical University - Xi’an, Shanxi, China