Epstein-Barr Virus (EBV) InfectionPhase 1/2NCT07133776
Application of PD-1 Inhibitors Combined With Tenofovir, Chidamide and Lenalidomide in the Treatment of EBV-associated Diseases.
A Phase 1/2 study testing PD-1 Inhibitor Combined with Tenofovir, Chidamide, and Lenalidomide for the Treatment of EBV Infectious Diseases. in people with Epstein-Barr Virus (EBV) Infection and PD-1 Inhibitor, run by The Affiliated Hospital of Xuzhou Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 75 years
- Conditions the study is for
- Epstein-Barr Virus (EBV) Infection, PD-1 Inhibitor, Tenofovir
- What is being tested?
- PD-1 Inhibitor Combined with Tenofovir, Chidamide, and Lenalidomide for the Treatment of EBV Infectious Diseases.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 coexisting hematologic disorders (e.g., hemophilia, myelofibrosis) deemed unsuitable for inclusion by the investigator;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
- Being tested
- PD-1 Inhibitor Combined with Tenofovir, Chidamide, and Lenalidomide for the Treatment of EBV Infectious Diseases.
- Keywords
- Epstein-Barr Virus (EBV) infection, PD-1 Inhibitor, tenofovir, Chidamide, lenalidomide
- Medical subject headings
- Epstein-Barr Virus Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: PD-1 Inhibitor Combined with Tenofovir, Chidamide, and Lenalidomide for the Treatment of EBV Infectious Diseases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR), including Complete Response (CR) and Partial Response (PR), based on EBV-DNA levels.
Measured: 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.
Proportion of patients alive at 24 months after initiation of tirelizumab combination therapy.
Measured: From first dose until death from any cause (assessed at 24 months）
24-month progression-free survival rate of EBV-infected diseases.
The proportion of patients with no disease progression at 24 months based on EBV DNA results.
Measured: From first dose until first documented progression or death (assessed at 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epstein-Barr Virus (EBV) InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133776
- Sponsor's protocol ID
- XYFY2025-KL294-01
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No