Spots Global Cancer Trial Database for Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT

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Trial Identification

Brief Title: Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT

Official Title: Multicenter, Open Label, Single-arm Exploratory Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT

Study ID: NCT06119256

Conditions

EBV Infection After Allogenic HSCT

Interventions

EBV-TCR-T cells

Study Description

Brief Summary: This is a multi-center, single arm, open-label, phase I study to determine the safety and effectiveness of EBV-TCR-T cell immunotherapy in treating EBV virus infection after allogenic HSCT.

Detailed Description: EB virus (EBV) infection after allogeneic hematopoietic stem cell transplantation (HSCT) is common and can be lethal without prompt treatment. In this prospective study, HLA-A\*02:01/11:01/24:02-restricted EBV-specific T cell receptor (TCR) will be introduced into the T cells of HSCT donors by ex vivo lentiviral transduction to generate EBV-TCR-T cells. An escalated dose ranging from 3×10\^5/kg to 1×10\^6/kg of EBV-TCR-T cells will be infused into patients with EBV infection. The safety, efficacy, pharmacokinetics and cytokine levels of allogenic EBV-TCR-T cell therapy will be evaluated.