NCT06195384

Anti-cancer Neoantigen mRNA Vaccine to Treat Solid Tumors

Anti-cancer Neoantigen mRNA Vaccine to Treat Advanced Solid Tumors: Phase I Clinical Trial

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate mRNA sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the mRNA vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the mRNA vaccine immunotherapy on human cancers will firstly be evaluated.

Detailed description

1. Choose appropriate patients with advanced solid cancers, with written consent for this study; 2. Perform biopsy to get fresh sample for DNA/RNA-seqencings and bioinformatics analysis; 3. Produce high quality mRNA vaccine and deliver the vaccine into selected patients via local injections, and follow up closely to collect related results as required; 4. To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied; 5. Evaluate the clinical results as needed.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
BIOLOGICAL	Neoantigen mRNA Vaccine	Deliver neoantigen mRNA vaccine into patients for anti-ancer therapy.

Timeline

• Start date: 2024-05-08
• Primary completion: 2027-12-30
• Completion: 2037-12-30
• First posted: 2024-01-08
• Last updated: 2024-06-26

Locations

1 site across 1 country: China