NCT05707910

Clinical Study of Therapeutic Immunological Agent for EBV-positive Advanced Malignant Tumors

A Phase I Study of the Efficacy and Safety of Therapeutic Immunological Agent for EBV-positive Advanced Malignant Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety of therapeutic immunological agent against EBV-positive advanced malignancies, examining the incidence, type of occurrence, and severity of adverse events in relation to the agent tested, and initially exploring the effectiveness of the immunological agent.

Detailed description

EBV (Epstein-Barr virus) is the first tumor-associated virus to be discovered, closely related to a variety of malignant tumors, including nasopharyngeal carcinoma (NPC), a variety of lymphomas, such as Hodgkin lymphoma (HL), non-Hodgkin lymphoma (NHL), Burkitt's lymphoma (BL) and partial EBV positive stomach cancer (EBV-associated Gastric Carcinomas, EBVaGC). Treatment of the above EBV+ tumors, surgery, radiotherapy and chemotherapy are still the main methods, immunotherapy for some patients has shown good efficacy, prolonging the patient's overall survival rate (Overall Survival, OS) and progression-free survival rate (Progression-Free-Survival, PFS), but the overall clinical efficacy needs to be further improved, and new treatment methods are urgently needed. After tumor cells are infected with EBV virus, they will express a variety of EBV virus antigens, which these proteins can promote the transformation and proliferation of human cells, inhibit cell apoptosis and participate in the occurrence and development of tumors, which also become candidate targets for research of immunotherapy because of the strong antigenicity of viral antigens. Therapeutic immunological agent was prepared which are naturally loaded with EBV antigens and present them to activate T cells and dendritic cells(DC) in vitro and significantly inhibit tumor growth in vivo. The agent also showed good safety. According to these findings suggest the therapeutic immunological agent provides a new idea for immunotherapy of EBV-related tumors. The findings suggest that a number of patients with malignant tumors who failed EBV+ multi-line therapy, including nasopharyngeal cancer, NK/T lymphoma, and gastric cancer needed to be treated with new immunotherapy method to achieve better outcomes.

Conditions

• Malignant Tumor

Interventions

Type	Name	Description
BIOLOGICAL	EBV immunological agent	2\*10\^7 and 5\*10\^7

Timeline

• Start date: 2023-02-08
• Primary completion: 2024-04-24
• Completion: 2027-12-31
• First posted: 2023-02-01
• Last updated: 2026-03-09

Locations

1 site across 1 country: China