RecruitingPhase 1Phase 2NCT07450391

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


Sponsor

Daihong Liu

Enrollment

18 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a specialized cell therapy called EBV-AST cells — immune cells grown in the lab that are trained to attack tumors driven by the Epstein-Barr virus (EBV), a common virus that in rare cases can cause serious blood cancers. The therapy is being tested in patients with EBV-associated lymphoproliferative disorders that have not responded to standard treatment. **You may be eligible if:** - You are between 18 and 75 years old - You have been diagnosed with an EBV-associated lymphoproliferative disorder (including EBV-positive DLBCL, NK/T-cell lymphoma, Hodgkin lymphoma, Burkitt lymphoma, or post-transplant lymphoproliferative disease) that is relapsed or refractory after prior treatment - Your HLA type matches at least one of the specific markers used in this therapy (HLA-A02:01, HLA-A11:01, or HLA-A*24:02) - You are in reasonably good functional health (Karnofsky score ≥70) - Your life expectancy is at least 3 months **You may NOT be eligible if:** - You have active and uncontrolled graft-versus-host disease (for transplant patients) - You have a known allergy to the cell product - You have inadequate organ or bone marrow function - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEBV-AST Cell Injection

EBV-AST is an Epstein-Barr virus (EBV) antigen-specific cytotoxic T-lymphocyte product generated by ex vivo stimulation and expansion of T cells using peptide-loaded dendritic cells. EBV-AST is administered by intravenous infusion every 2 weeks for up to 3 infusions at escalating dose levels (3×10\^5, 3×10\^6, or 3×10\^7 cells/kg per infusion), according to the protocol-defined dose-escalation design.


Locations(1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

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NCT07450391