Actively Recruiting
Multicenter, Open Label, Single-arm Exploratory Clinical Study of EBV-TCR-T Cells for EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection
Led by Chinese PLA General Hospital · Updated on 2023-11-18
9
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of EBV-TCR-T cell immunotherapy in patients with Epstein-Barr virus (EBV)-associated hemophagocytic lymphohistiocytosis (EBV-HLH) or EBV infection. This phase I, multi-center, open-label trial aims to understand how well this treatment works and its safety profile. EBV is a common herpesvirus that can cause serious complications like EBV-positive B-cell lymphomas and chronic infections when not controlled. The treatment involves creating EBV-specific T cell receptor (TCR) T cells by introducing a restricted EBV-specific TCR into donor T cells using lentiviral transduction. Patients with EBV-HLH or EBV infection will receive infusions of these EBV-TCR-T cells in escalating doses ranging from 1×10^6/kg to 1×10^8/kg. The trial is designed as a single-arm study where all participants receive the investigational EBV-TCR-T cell therapy. Participants will be monitored for adverse events for up to one year after treatment. The study will also assess dose-limiting toxicity, maximum tolerated dose, changes in EBV-DNA levels, and pharmacokinetics of the EBV-TCR-T cells. Regular evaluations include measuring cytokine levels, viral DNA copies, and cell concentration over time to understand treatment effects and safety. The total study duration and follow-up last through one year post-treatment.
CONDITIONS
Brief Title
Clinical Study of EBV-TCR-T Cells for EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 1 and 60 years, any gender
- Diagnosed with EBV-associated hemophagocytic lymphohistiocytosis (HLH) or EBV infection
- Fully informed about the study and signed the informed consent form
- Karnofsky Score 70 or higher for those 16 years or older, or Lansky Score 50 or higher for those under 16 years
- TCR-T cell donors must be 8 years or older, understand the study, sign consent, have at least 3 out of 6 HLA matches with recipients, have normal lymphocyte counts (0.8 to 4 x 10^9/L), and have sufficient venous access without symptoms preventing blood collection
You will not qualify if you...
- Uncontrolled active acute graft-versus-host disease (aGVHD) one day before infusion
- Severe kidney disease (creatinine over 3 times normal), liver damage (total bilirubin over 2.5 times normal, ALT and AST over 3 times normal), or heart failure (NYHA grade IV or ejection fraction below 50%) within one week before infusion
- Expected to take immunosuppressive hormones on infusion day
- Use of immunosuppressive drugs or G-CSF within 2 weeks before blood collection
- Presence of tumors or uncontrolled malignant diseases
- Positive for HIV antibodies or TAP antibodies
- Pregnant or breastfeeding women
- Men and women of childbearing potential who refuse contraception during the study
- Expected to receive other cell therapies within 4 weeks after infusion
- Participation in other clinical drug or device studies within 4 weeks before enrollment
- Allergy to albumin
- TCR-T cell donors who are pregnant; positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or TAP antibody; positive for EBV-DNA or CMV-DNA; have uncontrolled infections; or have used immunosuppressive drugs or G-CSF within 2 weeks before blood collection
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 - Up to 28 days after infusion
Participants receive infusions of EBV-TCR-T cells with escalated doses ranging from 1×10^6/kg to 1×10^8/kg.
Multiple visits for infusions and monitoring during the 28-day treatment period
Duration - Up to 1 year after treatment
Participants are monitored for safety, efficacy, and pharmacokinetics of the EBV-TCR-T cell therapy.
Regular visits during the 1-year follow-up period
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
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