NCT07133776Not yet recruitingPhase 1/2
Application of PD-1 Inhibitors Combined With Tenofovir, Chidamide and Lenalidomide in the Treatment of EBV-associated Diseases.
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
Source: ClinicalTrials.gov · Last updated 21 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- NCT number
- NCT07133776
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- From 1 Sept 2025 to the primary completion date, 1 Sept 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with severe concurrent infections;
- Patients who have undergone grade II or higher surgery within 3 weeks prior to treatment;
- Patients with known hypersensitivity to components of the investigational drug.
Other illness
- Patients with coexisting hematologic disorders (e.g., hemophilia, myelofibrosis) deemed unsuitable for inclusion by the investigator;
- Patients with substance abuse, medical, psychological, or social conditions that may interfere with study participation or the evaluation of study outcomes;
Lab values
- 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 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;
Other
- Patients who have experienced grade III or higher neurotoxicity within the past 2 weeks;
- Patients deemed unsuitable for enrollment by the investigator;
Who the study is looking for
- 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.
Age in the registry: 0 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.