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 (NeuMed-uPC)

The First Affiliated Hospital of Air Force Medicial University

Status and phase: Enrolling; Early Phase 1

Conditions: Unresectable Pancreatic Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07198659

KY20252120

Details and patient eligibility

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.

Full 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. 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).

Enrollment: 3 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Monomethyl Auristatin E (MMAE) / autologous neutrophil biological agents

Experimental group

Description:

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.

Treatment:

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