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

March 5, 2026 updated by: Xingchen Peng, West China Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female patients: ≥ 18 years old; ≤ 70 years old;
  2. Patients with EBV-positive advanced malignant tumors after failure of second-line standard therapy (including PD-1 inhibitor therapy);
  3. ECOG physical fitness score: 0~2 points;
  4. Estimated survival ≥ 3 months;

  5. The main organs have good function, that is, the relevant examination indicators within random 14 days meet the following requirements:

    1. Blood routine examination: hemoglobin ≥ 80 g/L (no blood transfusion within 14 days); Neutrophil count> 1.5×10^9/L; Platelet count≥ 80×10^9/L;
    2. Biochemical examination: total bilirubin ≤ 1.5× ULN (upper limit of normal); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN; If liver metastases are present, ALT or AST ≤ 5×ULN; Endogenous creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula);
    3. Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%.
  6. Sign the informed consent form;
  7. Good compliance, family members agree to cooperate with survival follow-up.

Exclusion Criteria:

  1. Participated in clinical trials of other drugs within 4 weeks;
  2. The patient has a history of other tumors, unless it is cervical cancer in situ, treated cutaneous squamous cell carcinoma or bladder epithelial tumor or other malignant tumor that has received radical treatment (at least 5 years before enrollment)
  3. Patients with uncontrolled cardiac clinical symptoms or diseases, such asheart failure above NYHA grade 2, unstable angina, myocardial infarction within 1 year, and clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
  4. For female subjects: pregnant or lactating women.
  5. The patient has active tuberculosis, bacterial or fungal infection; There is HIV infection with active HBV infection, HCV infection.
  6. Those who have a history of psychotropic drug abuse and have mental disorders who cannot be remitted;
  7. The subject has any active autoimmune disease or has a history of autoimmune disease (such as, but not limited to uveitis, enteritis, pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism, Participants with vitiligo or who had complete remission of asthma in childhood and did not require any intervention in adulthood could be included; Participants in asthma requiring medical intervention with bronchodilators were not included).
  8. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the patient's research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Cohort
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
Other Names:
  • Toripalimab 240mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: up to 12 months
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)
up to 12 months
Progress-Free Survival
Time Frame: up to 12 months
PFS is defined as the time from the administration of the first dose to first disease
up to 12 months
Overall Survival
Time Frame: up to 12 months
OS is defined as the time from the administration of the first dose to death.
up to 12 months
Adverse events
Time Frame: up to 12 months
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.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Investigators

  • Principal Investigator: Xingchen Peng, West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2023

Primary Completion (Actual)

April 24, 2024

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (Actual)

February 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-1389

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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