RecruitingPhase 1Phase 2NCT07368634

Exploratory Study of EBV-TCR-T Cell Injection for EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation

An Exploratory Clinical Study of EBV-TCR-T Cell Injection for the Treatment of EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation

Sponsor

Daihong Liu

Enrollment

18 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Post-Transplant Lymphoproliferative Disorder Epstein-Barr Virus Infection

Summary

Epstein-Barr virus (EBV) DNAemia is a common and potentially serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT) and may progress to EBV-associated lymphoproliferative disorders. Current treatment options are limited, and effective immune-based therapies are still needed. This is an investigator-initiated, exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of EBV-specific T cell receptor-engineered T cells (EBV-TCR-T cell injection) in patients with EBV DNAemia after allo-HSCT. Eligible participants will receive intravenous infusions of EBV-TCR-T cells at escalating dose levels. Safety outcomes, EBV-DNA clearance, and preliminary efficacy will be assessed, along with pharmacokinetic and pharmacodynamic characteristics of the infused cells.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called EBV-TCR-T Cell Injection for people with epstein-barr virus infection and post-transplant lymphoproliferative disorder. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEBV-TCR-T Cell Injection

EBV-TCR-T cell injection consists of Epstein-Barr virus-specific T cell receptor-engineered T lymphocytes manufactured from peripheral blood mononuclear cells. These cells are genetically modified to express EBV antigen-specific T cell receptors, enabling targeted recognition and elimination of EBV-infected cells. The EBV-TCR-T cells are administered by intravenous infusion at predefined dose levels according to the study protocol, with up to three infusions given at weekly intervals. This intervention is intended to evaluate the safety, tolerability, and preliminary efficacy of EBV-TCR-T cells in patients with EBV DNAemia following allogeneic hematopoietic stem cell transplantation.