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

NCT07133776 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: XYFY2025-KL294-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Epstein-Barr Virus (EBV) Infection; PD-1 Inhibitor; Tenofovir; Chidamide; Lenalidomide

Keywords

Epstein-Barr Virus (EBV) infection; PD-1 Inhibitor; tenofovir; Chidamide; lenalidomide

Outcome Measures

Primary Outcomes (1)

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

  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 Patients achieving CR or PR will continue treatment, while those with SD or PD will be withdrawn from the study.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 (2)

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

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

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

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

Study Arms (1)

Evaluate efficacy and safety of multi-drug therapy in EBV infectious diseases.

EXPERIMENTAL

To investigate the therapeutic effect of PD-1 inhibitor combined with tenofovir, chidamide, and lenalidomide in EBV infectious diseases, and to evaluate its safety and clinical benefit in this patient population.

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

Interventions

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.

Evaluate efficacy and safety of multi-drug therapy in EBV infectious diseases.

Eligibility Criteria

• Age: 0 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

MeSH Terms

Conditions

Epstein-Barr Virus Infections; Infections

Interventions

Tenofovir; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Lenalidomide

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Isoindoles

Central Study Contacts

Wei Sang

CONTACT

86+13645207648; xyfylbl515@xzhmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 21, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share