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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age0-75
SponsorThe Affiliated Hospital of Xuzhou Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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);

Trial design

Treatments tested in this trial

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

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations