Actively Recruiting
EBV-AST Cell Injection for EBV-Associated Lymphoproliferative Disorders
Led by Daihong Liu · Updated on 2026-03-04
18
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an investigator-initiated, open-label, single-arm, dose-escalation exploratory study to evaluate the safety, tolerability, and preliminary efficacy of EBV-AST cell injection in adults with EBV-associated lymphoproliferative disorders, including post-transplant lymphoproliferative disease (PTLD) and EBV-positive lymphomas. Participants will receive EBV-AST cell infusions intravenously every 2 weeks for up to 3 infusions at escalating dose levels. The primary objective is to assess safety and determine a potential optimal biologically active dose. Secondary objectives include preliminary tumor response and EBV-related virologic outcomes, as well as cellular PK/PD.
CONDITIONS
Official Title
EBV-AST Cell Injection for EBV-Associated Lymphoproliferative Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign written informed consent
- Age 18 to 75 years, inclusive
- HLA genotype matches at least one of the following: HLA-A02:01, HLA-A11:01, or HLA-A*24:02
- Karnofsky Performance Status (KPS) ≥ 70
- Life expectancy ≥ 3 months
- Diagnosed with EBV-associated lymphoproliferative disorders including relapsed/refractory post-transplant lymphoproliferative disorder after at least first-line therapy
- Diagnosed with EBV-associated lymphoma confirmed by histology and/or cytology with EBER positivity and relapsed/refractory or no suitable standard treatment available
- Absolute lymphocyte count ≥ 0.8 × 10^9/L (except for PTLD participants)
- Adequate organ and bone marrow function per protocol-defined criteria
- Participants of childbearing potential agree to use highly effective contraception throughout the study; women must have a negative pregnancy test at screening
You will not qualify if you...
- Known hypersensitivity to the investigational product or its components
- Uncontrolled active graft-versus-host disease in PTLD participants
- Known primary immunodeficiency disorders such as X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, chronic granulomatous disease, or hyper-IgE syndrome
- Severe uncontrolled medical conditions making the participant unsuitable for enrollment
- Serious cardiac disease within 6 months prior to first infusion
- Chronic diseases requiring systemic immunosuppressants or systemic steroids (except local/inhaled steroids or physiologic replacement therapy)
- History of other malignancy within the past 5 years except carcinoma in situ or non-melanoma skin cancer
- Receipt of lymphocyte-based immunotherapy within 3 months prior to consent
- Receipt of interferon or other targeted immunodeficiency drugs within 3 months prior to consent; prior high-dose IL-2 therapy
- Anti-cancer therapy within 14 days prior to consent; other cell therapy, live or attenuated vaccines, or investigational drugs within 28 days prior to consent; recent radiotherapy or major surgery within specified timeframes
- Prior immune therapy-associated grade 3 or higher immune-related adverse events
- Unresolved toxicity from prior therapy above grade 1 except certain exceptions
- Uncontrolled psychiatric or neurologic disorders; drug abuse or alcohol dependence
- Positive HIV antibody, positive Treponema pallidum antibody, active hepatitis B or C
- Uncontrolled severe active infection or contagious disease except EBV infection
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
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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