Exploratory Study of EBV-TCR-T Cell Injection for EBV DNAemia After Allogeneic Hematopoietic Stem… (NCT07368634) | Clinical Trial Compass
RecruitingPhase 1/2
Exploratory Study of EBV-TCR-T Cell Injection for EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation
China18 participantsStarted 2025-06-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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.
What they're measuring
1
Safety and Tolerability of EBV-TCR-T Cell Injection
Timeframe: From the first infusion up to 28 days after the last EBV-TCR-T cell infusion