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

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2028

Study Completion Date

September 30, 2029

Conditions
NK/T-cell LymphomaPeripheral T-cell Lymphoma (PTCL)DLBCL
Interventions
DRUG

EBV TCR-T

"After signing the informed consent form and completing screening according to the inclusion/exclusion criteria, eligible subjects will be sequentially assigned to the following dose cohorts of TCR-T cells (single administration): 1×10⁶ TCR-T cells/kg, 2.5×10⁶ TCR-T cells/kg, 5×10⁶ TCR-T cells/kg, and 10×10⁶ TCR-T cells/kg.~The first dose cohort (1×10⁶ TCR-T cells/kg) will use a rapid titration approach. If no significant safety issues occur within 28 days after infusion-defined as ≥Grade 3 non-hematologic toxicity, Grade 4 hematologic toxicity lasting more than 28 days (excluding disease- or chemotherapy-related causes), ≥Grade 2 neurotoxicity, or ≥Grade 3 cytokine release syndrome (CRS)-the next dose cohort will be initiated. If a dose-limiting toxicity (DLT) occurs, evaluation will be performed after 6 subjects have been treated.~The subsequent three dose cohorts will follow a 3+3 dose-escalation design, with 3-6 subjects per cohort receiving a single infusion. For subjects in th"

Trial Locations (1)

Unknown

RECRUITING

Shanghai General Hospital, Shanghai

All Listed Sponsors
lead

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER