Actively Recruiting
Multicenter, Open Label, Single-arm Exploratory Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT
Led by Chinese PLA General Hospital · Updated on 2026-04-02
12
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating EBV-TCR-T cell immunotherapy as a treatment for Epstein-Barr virus (EBV) infection occurring after allogeneic hematopoietic stem cell transplantation (HSCT). This is a phase 1, multi-center, open-label study focused on assessing the safety and effectiveness of this therapy in patients with hematologic malignancies who develop EBV infection following HSCT. The study aims to provide important information on how this treatment works and its potential risks. Patients will receive one to three infusions of EBV-specific T cell receptor (TCR) T cells derived from their HSCT donors. These EBV-TCR-T cells are created by introducing a specific TCR into donor T cells through lentiviral transduction. The infused doses will escalate from 5×10^5/kg up to 1×10^6/kg. A second phase will adjust dosing based on pharmacokinetics and patient response data. This therapy is delivered intravenously and closely monitored. Participants will be followed for up to one year after treatment, during which researchers will monitor adverse events, changes in EBV-DNA levels, persistence of the infused cells, and cytokine concentrations. Dose-limiting toxicities and maximum tolerated doses will also be evaluated within the first 28 days. Additional outcomes include response rates, duration of response, incidence of EBV-related complications, and pharmacokinetic parameters of the therapy. Safety and effectiveness assessments will involve laboratory tests, clinical evaluations, and follow-ups throughout the study period.
CONDITIONS
Brief Title
Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 14 to 75 years, any gender
- Diagnosed with hematologic malignancies and have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT) with EBV infection after allo-HSCT
- Karnofsky Score 270 (for age 16 years and older) or Lansky Score 250 (for under 16 years)
- TCR-T cell donors aged 8 to 70 years
- Donors must understand and voluntarily sign informed consent and comply with research procedures
- Donors must have at least a 3/6 HLA match with the recipient
- Donors must have lymphocyte count between 0.8 and 4 �d7 10^9/L
- Donors must have sufficient venous circulation and no symptoms preventing blood cell isolation
You will not qualify if you...
- Uncontrolled active acute graft-versus-host disease (aGVHD) one day before TCR-T cell infusion
- Severe kidney disease (creatinine >3 times normal), liver damage (total bilirubin >2.5 times normal, ALT and AST >3 times normal), or heart failure (NYHA grade IV) one week before infusion
- Expected to take immunosuppressive hormones on the day of TCR-T cell infusion
- Presence of other malignancies
- Relapsed and uncontrolled hematologic malignancies
- Positive for HIV antibodies or TAP antibodies
- Pregnant or breastfeeding women
- Expected to receive other cell therapies within 4 weeks after TCR-T cell infusion
- Participation in other clinical drug or medical device studies within 30 days before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies depending on number of infusions
Participants receive one to three infusions of donor-derived EBV-TCR-T cells to treat EBV infection after allogeneic hematopoietic stem cell transplantation.
1 to 3 infusion visits
Duration - Up to 1 year after treatment
Participants are monitored for safety, efficacy, pharmacokinetics, and cytokine levels after treatment with EBV-TCR-T cells.
Multiple follow-up visits during 1 year
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
D
Daihong Liu, Doctor
L
Liping Dou, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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