NCT06735508

MRNA Neoantigen Vaccine in Non-Small Cell Lung Cancer

An Exploratory Study of the Personalized MRNA Neoantigen Vaccine in Combination with Adebrelimab As Adjuvant Treatment for Patients with Resected Non-small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Brief Summary: This study is an open, prospective, exploratory clinical trial designed to evaluate the safety,ability, immunogenicity, and preliminary efficacy of a personalized neoantigen mRNA vaccine in combination with adebelimab as adjuvant treatment for patients with non-small cell lung cancer (NSCLC). The primary objectives of this study are to answer the following key questions: 1. The incidence of dose-limiting toxicities (DLTs) during the designated observation period. 2. The incidence and severity of adverse events (AEs) and serious adverse events (SAEs). 3. The determination of the maximum tolerated dose (MTD) or maximum administered dose (MAD).

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	mRNA Neoantigen Vaccine	mRNA Neoantigen Vaccine
DRUG	Adebrelimab	Adebrelimab is a programmed death-ligand 1 antibody.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-12-16
• Last updated: 2024-12-16

Locations

1 site across 1 country: China