DC Vaccines Targeting Epstein-Barr Virus for Patients with EBV-positive Nasopharyngeal Carcinoma

A Phase I Study on the Safety and Efficacy of a Personalized Neoantigen Primed Dendritic Cell Vaccine for Nasopharyngeal Carcinoma

Status

Active, not recruiting

Phases

Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200060423

Enrollment

Unknown

Registered

2022-06-01

Start date

2022-05-20

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nasopharyngeal carcinoma

Interventions

Experimental group:DC Vaccines Targeting Epstein-Barr Virus

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years. 2. The patients have signed the informed consent, understood the purpose, procedure and content of the study, and voluntarily participated in the study. 3. The patient was pathologically confirmed as nasopharyngeal carcinoma, and was still positive for Epstein-Barr virus after treatment. 4. Previous second - and third-line chemotherapy and targeted therapy failed. 5. Life expectancy > 90 days, Karnofsky score > 60. 6. Adequate organ function, with results of blood routine, liver and kidney function, and blood coagulation laboratory tests meeting the following criteria within 7 days before the initiation of treatment: Leukocyte (WBC) >= 3.5x10^9/L, platelet (PLT) >= 80x10^9/L, neutrophil (ANC) >= 1.5x10^9/L, hemoglobin (HGB) >= 90g/L, aspartate aminotransferase (AST) < 2.5x upper limit of normal (ULN) (liver metastasis < 5xULN), alanine aminotransferase (ALT) < 2.5xULN (liver metastasis < 5xULN), total bilirubin (TIBC) < 1.5xULN, serum creatinine (CR) < 1.0xULN, the prothrombin time, partial thrombin time, plasma fibrinogen and thrombin time were within the normal range.

Exclusion criteria

Exclusion criteria: 1. Have an active viral or bacterial infection and fail to control it with appropriate anti-infective therapy. 2. Known positive serologic reaction for HIV or syphilis, active hepatitis B virus or hepatitis C virus infection. 3. Patients with mental illness or other conditions cannot cooperate with research treatment and monitoring requirements. 4. Patients who are known to be allergic to any of the components in cultured cells. 5. Active rheumatic diseases. 6. Organ transplants. 7. Poor compliance. 8. Pregnant patients or lactating patients.

Design outcomes

Primary

Measure	Time frame
Safety of DC cells vaccine;Immunogenicity of a neoantigen-primed DC cell vaccine;Survival time and disease-free survival;Objective response rate;	—

Countries

China

Contacts

Public ContactJiang Jinxing

Shenzhen People's Hospital

jiang.jinxing@szhospital.com+86 755 22942466

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026