NCT05749627

Using Neoantigen Peptide Vaccine/neoantigen-based DC to Treat Advanced Malignant Solid Tumors

A Clinical Study of Personalized Tumor Neoantigen Peptide Vaccine/neoantigen-based Dendritic Cells in the Treatment of Advanced Malignant Solid Tumors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The First Affiliated Hospital of Nanchang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

In this study, the investigators provide a personalized tumor neoantigen peptide vaccine/neoantigen-based DC treatment to patients with advanced malignant solid tumors. The investigators observe the post-treatment tumor burden status, the immune response induced by immune preparations, and the prolongation of patient survival time, aiming to evaluate the effectiveness and safety of the neoantigen-based DC treatment.

Detailed description

This study is conducted in accordance with the Declaration of Helsinki and the guidelines of the Consolidated Standards of Reporting Trials. 20 patients with primary or metastatic melanoma, gastrointestinal tumor, breast cancer, cervical cancer, pancreatic cancer, lung cancer, or other malignant tumors will be recruited in this study. With doctor's assessment, a personalized tumor neoantigen peptide vaccine or neoantigen-based DC treatment plan will be designed for each participant： 1. Collecting venous blood samples; 2. Blood PBMC exome sequencing; 3. RNA transcriptome sequencing; 4. Classifying HLA alleles; 5. Performing bioinformatics analysis, finding meaningful mutations and about 10 neoantigen sequences for each patient; 6. Synthesizing peptide neoantigens; 7. Preparation of the personalized tumor neoantigen peptide vaccine or generating the personalized tumor neoantigen DC therapeutic immune preparation. Participants will receive 5-6 subcutaneous injections of the vaccine or DC preparation within a treatment period of 14 weeks. After treatment, participants will have 3 follow-up visits during 9-months. Venous blood collection, physical examination, ECOG Performance Status Scale assessment, CT/MRI scan, X-ray examination, laboratory examination, and other necessary examinations are required at each follow-up visit.

Conditions

• Advanced Malignant Solid Tumors

Interventions

Type	Name	Description
DRUG	Neoantigen peptide vaccine	Personalized tumor neoantigen peptide vaccine
DRUG	Neoantigen-based DC immune preparation	Personalized tumor neoantigen DC therapeutic immune preparation

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-03-01
• Last updated: 2025-02-27

Locations

1 site across 1 country: China