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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
EBV-TCR-T Cell Injection
Biological/VaccineEBV-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.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: EBV-TCR-T Cell InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From the first infusion up to 28 days after the last EBV-TCR-T cell infusionSecondary outcomes
1
EBV DNA Clearance Rate
EBV DNA clearance rate is defined as the proportion of participants who achieve EBV DNA negativity in peripheral blood following EBV-TCR-T cell infusion, as measured by quantitative polymerase chain reaction (qPCR).
Time frame
Up to 3 months after the first EBV-TCR-T cell infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Daihong Liu
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
Source ClinicalTrials.gov