CELL INTELLIGENCE · 肿瘤细胞治疗研究

Inclusion Criteria:

* 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 Criteria:

* 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.

主要终点：Safety and Tolerability of EBV-TCR-T Cell Injection · Safety and tolerability will be assessed by the incidence, nature, and severity of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) following EBV-TCR-T cell infusion. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE). Immune-related adverse events, including cytokine release syndrome and other infusion-related reactions, will be closely monitored throughout the study. · From the first infusion up to 28 days after the last EBV-TCR-T cell infusion
次要终点：EBV DNA Clearance Rate

• EBV-TCR-T Cell Injection · EXPERIMENTAL · Participants enrolled in this arm will receive EBV-specific T cell receptor-engineered T cells (EBV-TCR-T cell injection) administered by intravenous infusion. EBV-TCR-T cells are genetically modified T lymphocytes designed to recognize and eliminate Epstein-Barr virus-infected cells. Participants will receive EBV-TCR-T cell infusions at predefined dose levels according to the study protocol. Infusions are administered weekly, with up to three infusions given on Day 0, Day 7, and Day 14, depending on safety and virologic response. Safety, tolerability, and preliminary efficacy will be evaluated throughout the study.

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.