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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monomethyl Auristatin E (MMAE) / autologous neutrophil biological agents | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monomethyl Auristatin E (MMAE) / autologous neutrophil biological agents | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To verify the safety of Autologous Drug-Loaded Neutrophils (NeuMed) in patients with Unresectable Pancreatic Cancer | Incidence rate of Adverse Events(For the grading of treatment-related adverse events, all cases were classified with reference to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)). Developed by the National Cancer Institute (NCI), the Common Terminology Criteria for Adverse Events (CTCAE) is currently the most widely used adverse event (AE) grading system, applicable to oncology clinical trials. It classifies adverse events into 5 grades:Grade 1 (Mild): Asymptomatic or mild in severity, with no requirement for intervention;Grade 2 (Moderate): Requiring medical intervention and causing mild impairment of daily activities;Grade 3 (Severe): Resulting in significant functional impairment, necessitating hospitalization or substantial medical intervention, and rendering the patient unable to perform daily activities;Grade 4 (Life-threatening): Pose a threat to life and require urgent intervention;Grade 5 (Death): Directly caused by the adverse event. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the anti-tumor efficacy of Autologous Drug-Loaded Neutrophils (NeuMed) in patients with Unresectable Pancreatic Cancer | Objective Response Rate (ORR)ï¼›The ORR is determined by measuring the size of target and non-target tumor lesions in follow-up imaging data, in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST). The Response Evaluation Criteria in Solid Tumors (RECIST) classifies tumor response to treatment into distinct categories based on changes in the size of target lesions (and non-target lesions, as applicable) and the presence of new lesions, with the following specific grading framework:Complete Response (CR)ï¼›Partial Response (PR)ï¼›Stable Disease (SD)ï¼›Progressive Disease (PD). Imaging modalities for lesion measurement (e.g., contrast-enhanced CT, MRI) must be consistent throughout follow-up to ensure the reliability of SLD calculations, as mandated by the specific grading criteria in RECIST. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Jin, Doctor of Medicine(M.D.) | Contact | 02984775260 | 18392388395 | jinl2013@163.com |
| Lin Wang, Doctor of Medicine(M.D.) | Contact | 02984775260 | 13709113260 |
| Name | Affiliation | Role |
|---|---|---|
| Lin Wang, Doctor of Medicine(M.D.) | The First Affiliated Hospital of Air Force Military Medical University | Study Director |
| Liang Jin, Doctor of Medicine(M.D.) | The First Affiliated Hospital of Air Force Military Medical University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of the PLA Air Force Military Medical University | Recruiting | Xi’an | Shanxi | 710000 | China |
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| 12 months |
| Yong Chen, Doctor of Medicine(M.D.) | The First Affiliated Hospital of Air Force Military Medical University | Principal Investigator |
| ID | Term |
|---|---|
| C495575 | monomethyl auristatin E |
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