Exploratory Study of EBV-TCR-T Cell Injection for EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorDaihong Liu
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- EBV-TCR-T Cell Injection
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Daihong Liu
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
Source ClinicalTrials.gov