Autologous neutrophils carrying MMAE for unresectable pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-arm early-phase study gives patients with histologically confirmed unresectable pancreatic cancer infusions of their own neutrophils that are isolated, processed in a GMP-compliant lab, and loaded with the anti-tumor agent monomethyl auristatin E (MMAE). The primary focus is to determine safety and tolerability, with secondary observation of preliminary anti-tumor activity. Eligible adults (18–70) must have adequate organ function and ECOG ≤2, and may have progressed after standard first-line therapy or voluntarily opt in instead of standard treatment. Participants will be treated and monitored at a single center in Xi’an, China, with regular checks for adverse events and tumor response.

Why it matters

Who can join: the full rules

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's running

• The First Affiliated Hospital of the PLA Air Force Military Medical University
  Xi’an, Shanxi, China Recruiting

Study contacts

• Principal investigator: Liang Jin, Doctor of Medicine(M.D.) — The First Affiliated Hospital of Air Force Military Medical University
• Study coordinator: Liang Jin, Doctor of Medicine(M.D.)
• Email: jinl2013@163.com
• Phone: 02984775260

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.