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NCT Number: NCT07133776

Application of PD-1 Inhibitors Combined With Tenofovir, Chidamide and Lenalidomide in the Treatment of EBV-associated Diseases.

Currently, treatment options for Epstein-Barr virus (EBV) infection are limited, with unsatisfactory efficacy and no established standard therapy. Therefore, our center is conducting a prospective, multicenter, single-arm clinical trial to evaluate the efficacy and safety of PD-1 inhibitor in combination with tenofovir, chidamide, and lenalidomide in patients with EBV infectious diseases, aiming to provide a more effective and safer therapeutic option for EBV infectious diseases.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with EBV infectious diseases, including infectious mononucleosis, chronic active EBV infection, or other EBV infectious diseases;
  • EBV DNA ≥ 10⁴ copies/mL in whole blood or plasma;
  • Age ≤ 75 years with ECOG performance status ≤ 2;
  • Estimated life expectancy over 3 months;
  • Patients must be able to undergo follow-up. They should understand the nature of their disease and voluntarily agree to participate in this study for treatment and follow-up.

Exclusion criteria

  • Patients with impaired liver or kidney function, specifically defined as serum direct bilirubin, indirect bilirubin, and/or ALT, AST, or serum creatinine >2 times the upper limit of normal (ULN), unless such abnormalities are attributed to lymphoma;
  • Patients with bone marrow failure, defined as absolute neutrophil count (ANC) <1.5×10⁹/L or platelets <75×10⁹/L;
  • Patients who have experienced grade III or higher neurotoxicity within the past 2 weeks;
  • Patients with chronic heart failure classified as NYHA class III or IV, or left ventricular ejection fraction (LVEF) <50%, or those with a history of the following cardiac events within the past 6 months: acute coronary syndrome, acute heart failure (NYHA class III or IV), or significant ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, or resuscitated sudden cardiac arrest);
  • Patients with AIDS, syphilis, or active hepatitis B (HBV DNA >1×10⁴ copies/mL) or hepatitis C infection;
  • Patients with coexisting hematologic disorders (e.g., hemophilia, myelofibrosis) deemed unsuitable for inclusion by the investigator;
  • Patients with severe concurrent infections;
  • Patients who have undergone grade II or higher surgery within 3 weeks prior to treatment;
  • Patients with substance abuse, medical, psychological, or social conditions that may interfere with study participation or the evaluation of study outcomes;
  • Patients deemed unsuitable for enrollment by the investigator;
  • Patients with known hypersensitivity to components of the investigational drug.

Treatment and study plan

PD-1 Inhibitor Combined with Tenofovir, Chidamide, and Lenalidomide for the Treatment of EBV Infectious Diseases.

Drug

This study involves a four-drug combination regimen consisting of a PD-1 inhibitor, tenofovir, chidamide, and lenalidomide for the treatment of EBV Infectious diseases, aiming to inhibit viral replication and restore immune function through multiple mechanisms. The intervention includes not only pharmacological treatment but also pre-treatment assessments (such as EBV-DNA load, immune status, cardiac and renal function), efficacy monitoring during treatment (e.g., ORR, changes in EBV-DNA), and post-treatment follow-up for safety and survival outcomes (including OS, PFS, and adverse events), in order to comprehensively evaluate the clinical value and feasibility of this combination therapy.

Primary outcomes

  1. Overall Response Rate (ORR), including Complete Response (CR) and Partial Response (PR), based on EBV-DNA levels.

    Time frame: After 3 months of treatment according to the study protocol, a comprehensive efficacy assessment will be conducted. Patients achieving CR or PR will continue treatment, while those with SD or PD will be withdrawn from the study.

Secondary outcomes

  1. 24-month overall survival rate of EBV-infected diseases.

    Time frame: From first dose until death from any cause (assessed at 24 months)

    Proportion of patients alive at 24 months after initiation of tirelizumab combination therapy.

  2. 24-month progression-free survival rate of EBV-infected diseases.

    Time frame: From first dose until first documented progression or death (assessed at 24 months)

    The proportion of patients with no disease progression at 24 months based on EBV DNA results.

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Sang

CONTACT

[email protected]

86+13645207648

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Xuzhou Medical University

Other

Registry information

Official study title

A Multicenter, Single-Arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of PD-1 Inhibitor Combined With Tenofovir, Chidamide, and Lenalidomide in the Treatment of EBV-Associated Diseases

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2025
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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