Clinical Trial

Safety and Tolerability of a mRNA Vaccine Encoding Tumor-Specific Circular RNA Antigens in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors

Not Yet Recruiting Phase 1/2
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Summary
This is an Investigator-initiated, Open-Label Clinical Study of a mRNA Vaccine Encoding Tumor-Specific Circular RNA Antigens in Combination with anti-PD-1 monoclonal antibody in Patients with Advanced Solid Tumors. Preclinical studies of this project have identified that circFAM53B, which is specifically overexpressed in tumor cells, possesses the ability to encode a cryptic peptide, FAM53B-219aa, representing a potential tumor vaccine target. In this study, the sequence encoding the cryptic antigen from circFAM53B will be linearized and formulated as an mRNA vaccine (circFAM53B mRNA injection). The vaccine will be administered via lipid nanoparticle (LNP) encapsulation, and its safety and efficacy will be evaluated in combination with anti-PD-1 monoclonal antibody therapy.
Trial Details
NCT Number NCT07245901
Lead Sponsor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators: Zenith Institute of Medical Sciences, Guangzhou
Conditions Solid Tumor
Enrollment 60 participants
Start Date 2025-12-05
Primary Completion 2028-12-05 (estimated)
Study Completion 2030-12-05 (estimated)
Updated on ClinicalTrials.gov 2025-11-24