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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
EBV-AST Cell Injection
Biological/VaccineEBV-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.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: EBV-AST Cell InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-Limiting Toxicities (DLTs)
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.
Time frame
From first infusion (Day 0) through Day 282
Safety: Incidence of Adverse Events
Number of participants with treatment-emergent adverse events (AEs), immune-related adverse events (irAEs), and serious adverse events (SAEs), graded according to NCI CTCAE v5.0, including clinically significant laboratory abnormalities.
Time frame
From first infusion (Day 0) through 12 months after first infusion3
Recommended/Optimal Biologically Active Dose (OBD)
Recommended/optimal biologically active dose (OBD) of EBV-AST, determined based on the incidence of DLTs, overall safety profile, and tolerability across dose levels.
Time frame
Up to 28 days after first infusion for DLT evaluation; overall dose decision through study completionSecondary outcomes
1
Objective Response Rate (ORR)
Objective response rate (ORR), defined as the proportion of participants achieving complete response (CR) or partial response (PR) according to protocol-defined response criteria.
Time frame
From first infusion (Day 0) through 12 months after first infusion2
Disease Control Rate (DCR)
Disease control rate (DCR), defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) according to protocol-defined criteria.
Time frame
From first infusion (Day 0) through 12 months after first infusion3
Progression-Free Survival (PFS)
Progression-free survival (PFS), defined as the time from first EBV-AST infusion to documented disease progression or death from any cause.
Time frame
From first infusion (Day 0) through 12 months after first infusion4
Overall Survival (OS)
Overall survival (OS), defined as the time from first EBV-AST infusion to death from any cause.
Time frame
From first infusion (Day 0) through 12 months after first infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Daihong Liu
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
Source ClinicalTrials.gov