Personalized Neoantigen Cancer Vaccine for Patients With Solid Tumors

Summary

This clinical trial aims to evaluate the safety, immunogenicity, and preliminary efficacy of a personalized neoantigen peptide vaccine in patients with advanced cancer or at high risk of recurrence. The study is designed for patients whose tumors have specific mutations identifiable through genomic sequencing. These mutations, known as neoantigens, are unique to each patient's cancer and serve as the target for the personalized vaccine. Eligible patients will undergo genomic analysis, including whole exome sequencing and RNA sequencing, to identify these neoantigens. A custom peptide vaccine will then be produced and formulated to target these neoantigens. The trial consists of a preparation phase, a treatment phase with priming and booster vaccinations, and a follow-up/maintenance period of one year. The study will assess immune responses, clinical efficacy, and potential toxicities. By leveraging the immune system's ability to recognize and attack cancer cells, this vaccine aims to provide a new treatment option for patients with limited alternatives.

Timeline

Start

2022-11-24

Primary completion

2025-08-15

Completion

2025-08-15

Drugs

Indications