NCT07438067

EBV-AST Cell Therapy for EBV-Related Diseases After Stem Cell Transplantation

A Prospective Exploratory Study of EBV-AST Cell Injection for the Treatment of EBV-Related Diseases After Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Daihong Liu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This exploratory clinical study focuses on the use of EBV-AST cell infusion for treating EBV-DNA viremia following allogeneic hematopoietic stem cell transplantation (Allo-HSCT). The study aims to determine the maximum tolerated dose (MTD) or optimal biological dose (OBD) of EBV-AST cells and assess their safety, tolerability, and preliminary efficacy in treating EBV-DNA viremia. The study will involve a 3+3 dose escalation design to evaluate three different dosages of EBV-AST cell infusion. The study is expected to provide important insights into the clinical application of cell-based therapies for EBV infections.

Detailed description

This clinical trial, initiated by the First Medical Center of the Chinese People's Liberation Army General Hospital, will recruit patients who have experienced EBV-DNA viremia following Allo-HSCT. Patients eligible for inclusion must exhibit EBV-DNA viremia that requires clinical intervention and should meet the inclusion criteria set for the study. The research employs a 3+3 dose escalation methodology where three dosage groups are evaluated: 3×10\^5 cells/Kg, 1×10\^6 cells/Kg, and 3×10\^6 cells/Kg. Each patient will receive up to three infusions, one per week. The study will monitor both the safety and the preliminary efficacy of the infusions, including their ability to reduce EBV-DNA levels and the duration of EBV-DNA negativity. The trial will also assess the pharmacokinetics (PK) and pharmacodynamics (PD) of the EBV-AST cell infusion.

Conditions

• EBV-DNA Viremia
• Post-Transplant Lymphoproliferative Disorder

Interventions

Type	Name	Description
BIOLOGICAL	EBV-AST cell	EBV-AST (EBV-specific cell infusion) for the treatment of EBV-DNA viremia and prevention of PTLD in patients post-Allo-HSCT.

Timeline

• Start date: 2025-03-26
• Primary completion: 2028-03-26
• Completion: 2028-03-26
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: China