Clinical trial · Interventional
EBV-AST Cell Injection for EBV-Associated Lymphoproliferative Disorders
Exploratory Clinical Study of EBV-AST Cell Injection for the Treatment of EBV-Associated Lymphoproliferative Disorders
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EBV-Positive Lymphoma | — | UNRESOLVED | — |
| Epstein-Barr Virus-Associated Lymphoproliferative Disorders | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EBV-AST Cell Injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EBV-AST Cell Injection
- description
- Participants with EBV-associated lymphoproliferative disorders (including PTLD and EBV-positive lymphomas) will receive EBV-AST cell injection by intravenous infusion in a dose-escalation scheme. EBV-AST is administered every 2 weeks for up to 3 infusions (Day 0, Day 14, and Day 28). Three dose levels are planned: 3×10\^5, 3×10\^6, and 3×10\^7 cells/kg per infusion, with dose-escalation decisions based on safety and protocol-defined criteria.
- interventionNames
- Biological: EBV-AST Cell Injection
Primary outcomes (3)
- measure
- Dose-Limiting Toxicities (DLTs)
- timeFrame
- From first infusion (Day 0) through Day 28
- description
- Number of participants experiencing dose-limiting toxicities (DLTs) within 28 days after the first EBV-AST cell infusion, as defined by protocol-specific criteria and graded according to NCI CTCAE v5.0.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Able to understand and voluntarily sign written informed consent. 2. Age 18 to 75 years, inclusive. 3. HLA genotype matches at least one of the following: HLA-A02:01, HLA-A11:01, or HLA-A\*24:02. 4. Karnofsky Performance Status (KPS) ≥ 70. 5. Life expectancy ≥ 3 months. 6. Diagnosed with EBV-associated lymphoproliferative disorders, including: 7. EBV infection-associated post-transplant lymphoproliferative disorder (PTLD) that is relapsed/refractory after at least first-line standard therapy; or 8. EBV-associated lymphoma confirmed by histology and/or cytology with EBER positivity (ISH/FISH), with no standard treatment available or not suitable for standard therapy, including but not limited to: EBV-positive DLBCL, EBV-positive NK/T-cell lymphoma, EBV-positive Hodgkin lymphoma, EBV-positive Burkitt lymphoma, EBV-positive nodal TFH lymphoma (AITL type), and EBV-positive primary cutaneous T-cell lymphoma, meeting protocol-defined relapsed/refractory criteria. 9. Absolute lymphocyte count ≥ 0.8 × 10\^9/L (except for PTLD participants). 10. Adequate organ and bone marrow function per protocol-defined criteria. 11. Participants of childbearing potential agree to use highly effective contraception throughout the study; women of childbearing potential must have a negative pregnancy test at screening. Exclusion Criteria: 1. Known hypersensitivity to the investigational product or its components. 2. Uncontrolled active graft-versus-host disease (GVHD) in PTLD participants. 3. Known primary immunodeficiency disorders (e.g., X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, chronic granulomatous disease, hyper-IgE syndrome). 4. Severe uncontrolled medical conditions that, in the investigator's judgment, make the participant unsuitable for enrollment. 5. Serious cardiac disease within 6 months prior to first infusion (e.g., myocardial infarction, severe/unstable angina, bypass surgery, NYHA class III-IV heart failure). 6. Chronic diseases requiring systemic immunosuppressants or systemic steroids (except local/inhaled steroids or physiologic replacement therapy). 7. History of other malignancy within the past 5 years, except carcinoma in situ (e.g., cervix, bladder, breast) or non-melanoma skin cancer. 8. Receipt of lymphocyte-based immunotherapy (e.g., CIK, DC, DC-CIK, LAK) within 3 months prior to consent. 9. Receipt of interferon or other targeted immunodeficiency drugs within 3 months prior to consent; prior high-dose IL-2 therapy. 10. Anti-cancer therapy within 14 days prior to consent (including chemotherapy or immunosuppressants/steroids); other cell therapy or live vaccines/attenuated vaccines or other investigational drugs within 28 days prior to consent; curative radiotherapy or major surgery within 4 weeks, or palliative local radiotherapy within 2 weeks prior to consent. 11. Prior immune therapy-associated ≥ Grade 3 immune-related adverse events (irAEs). 12. Unresolved toxicity from prior therapy \> Grade 1 (except alopecia any grade; peripheral sensory neuropathy ≤ Grade 2). 13. Uncontrolled psychiatric or neurologic disorders; drug abuse or alcohol dependence. 14. Positive HIV antibody; positive Treponema pallidum antibody; active hepatitis B (HBsAg and/or HBeAg positive with HBV-DNA above ULN) or active hepatitis C (HCV-Ab positive and HCV-RNA positive). 15. Uncontrolled severe active infection or contagious disease (excluding EBV infection). 16. Pregnant or breastfeeding women.
References
Publications (0)
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