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

NCT07162012 - Safety and Efficacy of Anti-EBV Autologous TCR-T Cell Injection in Relapsed/Refractory EBV-Positive Lymphoma | Biotech Hunter | Biotech Hunter