A Phase 1 interventional study of EBV immunological agent in Malignant Tumor, sponsored by West China Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by West China Hospital · Phase 1, Interventional, and Treatment
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 6 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →West China Hospital is the lead sponsor of 483 studies on the registry; 240 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The main organs have good function, that is, the relevant examination indicators within random 14 days meet the following requirements:
Exclusion Criteria:
EBV immunological agent administration on day 0,7,14,28 and 60 for subcutaneous injection.
Biological: EBV immunological agent
2\*10\^7 and 5\*10\^7
Also known as: Toripalimab 240mg
Adverse events
The primary endpoint was safety, with adverse events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
Time frame: up to 12 months
Objective response rate
ORR is defined as the percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)
Time frame: up to 12 months
Progress-Free Survival
PFS is defined as the time from the administration of the first dose to first disease
Time frame: up to 12 months
Overall Survival
OS is defined as the time from the administration of the first dose to death.
Time frame: up to 12 months
Plan to share: No
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
West China Hospital