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

NCT07133776 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-21

No results posted yet for this study

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

Interventions

DRUG

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

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.

Sponsors & Collaborators

  • The Affiliated Hospital of Xuzhou Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-09-01
Completion
2027-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07133776 on ClinicalTrials.gov