Safety and Efficacy of Anti-EBV Autologous TCR-T Cell Injection for Relapsed or Refractory EBV-Positive Lymphoma Patients With HLA-A11:01

What this Trial Is About

Researchers are testing an anti-EBV autologous TCR-T cell injection for patients aged 18 to 70 years with relapsed or refractory EBV-positive lymphoma who have the HLA-A11:01 genetic type. This early phase 1 study aims to evaluate the safety, tolerability, and the maximum tolerated dose of the treatment. The trial will also observe how the infused T cells expand and persist, changes in EBV DNA levels and T-cell subgroups, and early signs of clinical benefit, while monitoring for immune responses against the infused cells. Participants will receive a single infusion of EBV TCR-T cells, assigned sequentially to increasing dose levels starting from 1x10^6 cells/kg up to 10x10^6 cells/kg. The first dose group uses rapid titration with safety monitoring for 28 days, followed by a traditional 3+3 dose escalation in subsequent groups. If dose-limiting toxicities occur, further evaluation will guide dosing decisions. This approach helps identify the recommended dose for future studies. During the study, participants will be closely monitored for dose-limiting toxicities during the first 28 days and throughout the dose-escalation phase. Researchers will collect blood samples over up to 24 months to track T cell persistence, EBV DNA, and immune cell changes. They will also assess treatment response, progression-free survival, and overall survival. Participants' health and organ functions will be regularly checked to ensure safety and to document any side effects or benefits.

Safety and Efficacy of Anti-EBV Autologous TCR-T Cell Injection in Relapsed/Refractory EBV-Positive Lymphoma