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

RecruitingPhase 1Ages 18 Years - 75 YearsAllDaihong Liu
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. The patient must be aged 18-75 years. 2. ust have undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT). 3. Must have EBV-DNA viremia post-transplant, with EBV-DNA \> 1000 copies/mL (on two consecutive tests or one test \> 10,000 copies/mL). 4. Karnofsky Performance Score (KPS) of 70 or higher. 5. Expected survival of at least 3 months. 6. Sufficient organ function, including renal (serum creatinine โ‰ค 1.5 ร— ULN and creatinine clearance โ‰ฅ 50 mL/min), hepatic (AST, ALT, and total bilirubin โ‰ค 5 ร— ULN), and hematologic parameters (platelets โ‰ฅ 10 ร— 10\^9/L, neutrophils โ‰ฅ 1.0 ร— 10\^9/L). 7. HLA-matching criteria must be met for the donor/recipient. Exclusion Criteria: 1. Active GVHD (Grade 2 or higher) or requiring \>0.5 mg/kg/day corticosteroids for GVHD. 2. History of CMV viremia or disease within the past week. 3. PTLD (Post-Transplant Lymphoproliferative Disorder) diagnosed or suspected within 1 week before infusion. 4. Severe active infections (excluding EBV and CMV). 5. Serious allergic reactions or contraindications to the infusion. 6. Previous immune therapy-related adverse events of Grade 3 or higher. 7. History of HIV, HCV, or HBV infection with an active viral load.
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What it tests

  • EBV-AST cell
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Where

1 site
Chinese PLA General Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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