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MRNA Neoantigen Vaccine in Non-Small Cell Lung Cancer

NCT06735508 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-12-16

No results posted yet for this study

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

Interventions

DRUG

mRNA Neoantigen Vaccine

mRNA Neoantigen Vaccine

DRUG

Adebrelimab

Adebrelimab is a programmed death-ligand 1 antibody.

Sponsors & Collaborators

  • Shanghai Regenelead Therapies Co., Ltd.

    collaborator INDUSTRY

  • Guangdong Provincial People's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06735508 on ClinicalTrials.gov