NCT06788600

Mechanistic Study of EBV mRNA Vaccine (WGc-043) in EBV-Positive Relapsed/Refractory Lymphoma

An EBV mRNA Vaccine (WGc-043 Injection) in Patients With EB Virus-positive Relapsed or Refractory Lymphoma: A Phase I Clinical Trial Assessing the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Anti-tumor Activity

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This exploratory study, based on a pharmaceutical company-initiated clinical trial, aims to investigate the therapeutic effects of the EBV mRNA vaccine (WGc-043 injection) in treating EBV-positive relapsed or refractory lymphoma. The study explores the mechanism of the EBV mRNA vaccine (WGc-043 injection) within the tumor microenvironment in EBV-positive lymphoma, elucidating the vaccine's inhibitory effects on EBV. This research will provide a theoretical foundation for the application of mRNA vaccines, either alone or in combination with other immunotherapies, in the treatment of EBV-positive lymphoma.

Conditions

• Epstein-Barr Virus Associated Lymphoma

Interventions

Type	Name	Description
DRUG	EBV mRNA vaccine (WGc-043)	Each subject will be infused with EBV mRNA vaccine per administration, including 5 doses for the primary immunization regimen and subsequent optional personalized treatment. For the primary immunization, the first 4 doses will be administered weekly, with the 5th dose given 4 weeks after the 4th dose. The specific dose of mRNA vaccine will be determined according to the experimental group.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2025-01-23
• Last updated: 2025-04-02

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study