NCT07133763

Application of PD-1 Inhibitors, Tenofovir, Chidamide, and Lenalidomide in Relapsed/Refractory EBV-associated Lymphoproliferative Disorders.

A Multicenter, Single-Arm, Prospective Study to Evaluate the Efficacy and Safety of PD-1 Inhibitor Combined With Tenofovir, Chidamide, and Lenalidomide in the Treatment of Relapsed or Refractory EBV-Associated Lymphoproliferative Disorders.

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The Affiliated Hospital of Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 0 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multicenter, single-arm clinical trial designed to evaluate the efficacy and safety of PD-1 inhibitor combined with tenofovir, chidamide, and lenalidomide in the treatment of relapsed or refractory Epstein-Barr virus (EBV)-associated lymphoproliferative disorders (LPDs). The primary endpoint is the overall response rate (ORR) at 3 months, including complete response (CR) and partial response (PR). Secondary endpoints include overall survival (OS), progression-free survival (PFS), as well as safety and tolerability assessments. Eligible patients must have histologically confirmed EBV-positive B-cell or T/NK-cell LPDs with measurable lesions. This combination regimen targets multiple mechanisms, including inhibition of EBV replication, activation of the immune system, and enhancement of antitumor effects, aiming to provide an innovative therapeutic strategy for this challenging disease.

Conditions

• EBV-Associated Lymphoproliferative Disorders
• PD-1 Inhibitor
• Tenofovir
• Chidamide
• Lenalidomide

Interventions

Type	Name	Description
DRUG	PD-1 Inhibitor Combined with Tenofovir, Chidamide, and Lenalidomide for the Treatment of EBV-Associated Lymphoproliferative Disorders.	This study investigates a novel multi-targeted regimen combining a PD-1 inhibitor, tenofovir, chidamide, and lenalidomide for relapsed/refractory EBV-associated lymphoproliferative disorders (LPDs). Unlike conventional therapies focused on antivirals or chemotherapy alone, this approach integrates antiviral suppression, epigenetic reactivation, immune modulation, and checkpoint blockade to achieve synergistic antitumor and antiviral effects. Preliminary data show effective EBV inhibition and tumor regression. This strategy offers a promising and distinct therapeutic option for EBV-driven lymphoid malignancies resistant to standard treatment.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-08-21
• Last updated: 2025-08-21