EBV-AST Cell Therapy for EBV-Related Diseases After Stem Cell Transplantation
Trial statusRecruiting
Trial phasePhase 1, Phase 2
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
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
Treatments tested in this trial
- EBV-AST cell
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