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

Launched by THE AFFILIATED HOSPITAL OF XUZHOU MEDICAL UNIVERSITY · Aug 14, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new combination treatment for diseases caused by the Epstein-Barr virus (EBV), which can cause infections like infectious mononucleosis and other serious conditions. The study is looking at whether using a type of medicine called a PD-1 inhibitor together with three other drugs—tenofovir, chidamide, and lenalidomide—can work better and be safer than current treatments. Right now, there aren’t many good options for treating EBV infections, so this trial hopes to find a more effective way to help patients.

People who might join this study are those diagnosed with an EBV infection and who have a certain level of the virus in their blood. Participants need to be 75 years old or younger, feel well enough to take part, and expect to live for at least three months. The study will carefully check safety and how well the treatment works, and patients will be followed up regularly. However, people with serious liver, kidney, heart problems, or other infections like hepatitis or AIDS, as well as those with certain blood disorders or recent major surgery, may not be able to join. This trial is not yet open for enrollment, but it aims to offer new hope for people affected by EBV-related diseases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosed with EBV infectious diseases, including infectious mononucleosis, chronic active EBV infection, or other EBV infectious diseases;
• • 2. EBV DNA ≥ 10⁴ copies/mL in whole blood or plasma;
• • 3. Age ≤ 75 years with ECOG performance status ≤ 2;
• • 4. Estimated life expectancy over 3 months;
• • 5. 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:
• • 1. 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;
• • 2. Patients with bone marrow failure, defined as absolute neutrophil count (ANC) \<1.5×10⁹/L or platelets \<75×10⁹/L;
• • 3. Patients who have experienced grade III or higher neurotoxicity within the past 2 weeks;
• • 4. 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);
• • 5. Patients with AIDS, syphilis, or active hepatitis B (HBV DNA \>1×10⁴ copies/mL) or hepatitis C infection;
• • 6. Patients with coexisting hematologic disorders (e.g., hemophilia, myelofibrosis) deemed unsuitable for inclusion by the investigator;
• • 7. Patients with severe concurrent infections;
• • 8. Patients who have undergone grade II or higher surgery within 3 weeks prior to treatment;
• • 9. Patients with substance abuse, medical, psychological, or social conditions that may interfere with study participation or the evaluation of study outcomes;
• • 10. Patients deemed unsuitable for enrollment by the investigator;
• • 11. Patients with known hypersensitivity to components of the investigational drug.