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
NCT ID: NCT07198659
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
3 participants
INTERVENTIONAL
2025-07-14
2027-07-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Air Force Medicial University
OTHER
Responsible Party
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Lin Wang
Professor
Principal Investigators
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Lin Wang, Doctor of Medicine(M.D.)
Role: STUDY_DIRECTOR
The First Affiliated Hospital of Air Force Military Medical University
Liang Jin, Doctor of Medicine(M.D.)
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Air Force Military Medical University
Yong Chen, Doctor of Medicine(M.D.)
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Air Force Military Medical University
Locations
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The First Affiliated Hospital of the PLA Air Force Military Medical University
Xi’an, Shanxi, China
Countries
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Central Contacts
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Lin Wang, Doctor of Medicine(M.D.)
Role: CONTACT
Facility Contacts
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Other Identifiers
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KY20252120
Identifier Type: -
Identifier Source: org_study_id
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