EBV-AST Cell Injection for EBV-Associated Lymphoproliferative Disorders
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorDaihong Liu
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Known hypersensitivity to the investigational product or its components.
Uncontrolled active graft-versus-host disease (GVHD) in PTLD participants.
Known primary immunodeficiency disorders (e.g., X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, chronic granulomatous disease, hyper-IgE syndrome).
Severe uncontrolled medical conditions that, in the investigator's judgment, make the participant unsuitable for enrollment.
Trial design
Treatments tested in this trial
- EBV-AST Cell Injection
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Daihong Liu
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
Source ClinicalTrials.gov