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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

RecruitingEARLY Phase 1Ages 18 Years - 70 YearsAllThe First Affiliated Hospital of Air Force Mediciโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค 2 and expected survival time โ‰ฅ 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
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What it tests

  • Monomethyl Auristatin E (MMAE) / autologous neutrophil biological agents
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Where

1 site
The First Affiliated Hospital of the PLA Air Force Military Medical University
Xiโ€™an, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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