Actively Recruiting
Exploratory Study of EBV-TCR-T Cell Injection for EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation
Led by Daihong Liu · Updated on 2026-01-28
18
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exploratory Study of EBV-TCR-T Cell Injection for EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at enrollment
- History of allogeneic hematopoietic stem cell transplantation
- Presence of Epstein-Barr virus DNAemia confirmed by quantitative PCR in blood
- EBV DNAemia persisting or increasing despite standard management
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate organ function as defined by the study protocol
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Diagnosis of EBV-associated lymphoproliferative disorder requiring immediate chemotherapy
- Active, uncontrolled infection other than EBV
- History of severe autoimmune disease requiring systemic immunosuppressive therapy
- Uncontrolled graft-versus-host disease requiring high-dose corticosteroids or immunosuppressives
- Prior EBV-specific adoptive T cell therapy within the required washout period
- Known active malignancy other than EBV-related disease interfering with participation
- Pregnant or breastfeeding women
- Any medical, psychological, or social condition that would interfere with safe participation as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, China
Actively Recruiting
Research Team
D
Daihong Liu
CONTACT
L
Liping Dou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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