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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Monomethyl Auristatin E (MMAE) / autologous neutrophil biological agents.
- Who it may be relevant to
- Registry conditions: Unresectable Pancreatic Cancer. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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）
Overview
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.
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. 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).
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.
Primary outcome measures
- To verify the safety of Autologous Drug-Loaded Neutrophils (NeuMed) in patients with Unresectable Pancreatic Cancer [Time frame: 12 months]
Secondary outcome measures (1)
- To assess the anti-tumor efficacy of Autologous Drug-Loaded Neutrophils (NeuMed) in patients with Unresectable Pancreatic Cancer [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of the PLA Air Force Military Medical University — Xi’an
Identifiers
NCT: NCT07198659 · KY20252120