Autologous neutrophils carrying MMAE for unresectable pancreatic cancer
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）
This will test whether a patient's own neutrophils, loaded with the chemotherapy drug MMAE, can help shrink or control unresectable pancreatic cancer.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 3 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Air Force Medicial University Academic / other |
| Locations | 1 site (Xi’an, Shanxi) |
| Trial ID | NCT07198659 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (18–70) with histologically confirmed unresectable pancreatic cancer, ECOG score ≤2, adequate liver/kidney/bone marrow function, and either prior standard therapy failure or a voluntary choice of this experimental therapy.
Not a fit: Patients with active infections, autoimmune or autoinflammatory disease, recent live vaccines, need for anticoagulation, severe cardiovascular/cerebrovascular or interstitial lung disease, poor organ function, or resectable disease are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could deliver chemotherapy directly to tumors using a patient's own immune cells, potentially improving tumor control while reducing systemic side effects.
How similar studies have performed: This cell-delivered chemotherapy approach is novel and primarily supported by preclinical or very early human data, with no clear success demonstrated in large human trials yet.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Xi’an, Shanxi
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.