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
Daihong Liu
18 participants
Jun 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- Age ≥ 18 years at the time of enrollment.
- History of allogeneic hematopoietic stem cell transplantation.
- Presence of Epstein-Barr virus (EBV) DNAemia confirmed by quantitative polymerase chain reaction (qPCR) in peripheral blood.
- EBV DNAemia persisting or increasing despite standard management, as determined by the investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate organ function as defined by the study protocol.
- Ability to understand and willingness to sign written informed consent.
Exclusion Criteria8
- Diagnosis of EBV-associated lymphoproliferative disorder requiring immediate cytotoxic chemotherapy.
- Active, uncontrolled infection other than EBV.
- History of severe autoimmune disease requiring systemic immunosuppressive therapy.
- Uncontrolled graft-versus-host disease requiring high-dose systemic corticosteroids or other immunosuppressive treatment.
- Prior treatment with EBV-specific adoptive T cell therapy within a defined washout period.
- Known active malignancy other than EBV-related disease that may interfere with study participation.
- Pregnant or breastfeeding women.
- Any medical, psychological, or social condition that, in the opinion of the investigator, would interfere with safe participation in the study.
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Interventions
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.
Locations(1)
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NCT07368634