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EBV-AST Cell Therapy for EBV-Related Diseases After Stem Cell Transplantation

ConditionEBV-DNA Viremia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDaihong Liu

About this trial

This exploratory clinical study focuses on the use of EBV-AST cell infusion for treating EBV-DNA viremia following allogeneic hematopoietic stem cell transplantation (Allo-HSCT). The study aims to determine the maximum tolerated dose (MTD) or optimal biological dose (OBD) of EBV-AST cells and assess their safety, tolerability, and preliminary efficacy in treating EBV-DNA viremia. The study will involve a 3+3 dose escalation design to evaluate three different dosages of EBV-AST cell infusion. The study is expected to provide important insights into the clinical application of cell-based therapies for EBV infections.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient must be aged 18-75 years.

ust have undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT).

Must have EBV-DNA viremia post-transplant, with EBV-DNA > 1000 copies/mL (on two consecutive tests or one test > 10,000 copies/mL).

Karnofsky Performance Score (KPS) of 70 or higher.

Disqualifiers

Active GVHD (Grade 2 or higher) or requiring >0.5 mg/kg/day corticosteroids for GVHD.

History of CMV viremia or disease within the past week.

PTLD (Post-Transplant Lymphoproliferative Disorder) diagnosed or suspected within 1 week before infusion.

Severe active infections (excluding EBV and CMV).

Trial design

Design model

Single group

Treatments tested in this trial

  • EBV-AST cell

    Biological/Vaccine

    EBV-AST (EBV-specific cell infusion) for the treatment of EBV-DNA viremia in patients post-Allo-HSCT.

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: EBV-AST cell infusionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum Tolerated Dose (MTD) of EBV-AST Cell Infusion

The primary outcome measure of the study is to determine the maximum tolerated dose (MTD) of EBV-AST cell infusion in patients with EBV-DNA viremia following allogeneic hematopoietic stem cell transplantation (Allo-HSCT). A dose-escalation design (5×10\^5, 1×10\^6, and 5×10\^6 cells/kg) will be used to evaluate safety and tolerability based on the occurrence of dose-limiting toxicities (DLTs).

Time frame
Day 1 through 28 days after each EBV-AST cell infusion during the dose escalation phase.

Secondary outcomes

1

Proportion of Patients Achieving EBV-DNA Negativity

The proportion of patients achieving EBV-DNA negativity following EBV-AST cell infusion.

Time frame
8 weeks and 12 weeks after EBV-AST cell infusion.
2

Change in EBV-DNA Levels

Change in EBV-DNA viral load from baseline following EBV-AST cell infusion.

Time frame
Baseline through 12 weeks after EBV-AST cell infusion.
3

Time to EBV-DNA Negativity

Time from EBV-AST cell infusion to first documented EBV-DNA negativity.

Time frame
Up to 12 weeks after EBV-AST cell infusion.
4

Absolute Concentration of Circulating EBV-AST Cells in Peripheral Blood at Pre-specified Time Points

Quantification of the absolute number of viable EBV-AST cells per microliter (μL) of peripheral blood using flow cytometry.

Time frame
Baseline through 28 days after EBV-AST cell infusion

Other outcomes

Sponsors 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
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