NCT06888648

Personalized Tumor Neoantigen MRNA Therapy for Advanced Pancreatic Cancer.

Clinical Study to Evaluate the Safety and Efficacy of Personalized Tumor Neoantigen MRNA Therapy in Combination with PD-1 Antibody and Chemotherapy for Advanced Pancreatic Cancer.

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm phase I/II clinical study to evaluate the effectiveness of evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy (iNeo-Vac-R01) in combination with PD-1 antibody and standard chemotherapy regimens for the treatment of patients with advanced pancreatic cancer.

Conditions

• Pancreatic Cancer Metastatic
• Pancreatic Cancer Non-resectable

Interventions

Type	Name	Description
BIOLOGICAL	individualized anti-tumor new antigen iNeo-Vac-R01 injection	The individualized anti-tumor new antigen iNeo-Vac-R01 injection was commissioned by Hangzhou Nuanjin Biotechnology Co., Ltd., and all patients were admitted into the therapeutic intervention group. According to the results of previous non-clinical studies, the individualized mRNA injection of 100 μ g was a tolerable dose.
DRUG	mFOLFIRINOX Treatment Regimen	continuous intravenous infusion of fluorouracil 2400mg / m², for 46 hours, leucovorin 400mg / m², irinotecan 135mg / m², and oxaliplatin 68mg / m², every 2 weeks
DRUG	Sintilimab injection	Sintilimab Injection, 200mg, intravenous infusion, every 3 weeks

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-04-01
• Completion: 2028-04-01
• First posted: 2025-03-21
• Last updated: 2025-03-21

Locations

1 site across 1 country: China