An Early Phase 1 interventional study of EBV TCR-T in NK/T-cell Lymphoma, Peripheral T-cell Lymphoma (PTCL) and DLBCL, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Early Phase 1, Interventional, and Treatment
This study will test whether anti-EBV autologous TCR-T cell injection is safe and effective for patients with relapsed or refractory EBV-positive lymphoma who have HLA-A11:01. Researchers will look at safety, tolerability, and the maximum tolerated dose or recommended dose for future studies.
The study will also measure how the infused TCR-T cells expand and persist in the body, changes in EBV DNA levels and T-cell subgroups in the blood, and whether the treatment shows early signs of clinical benefit. Researchers will also explore whether the treatment causes an immune response against the infused cells.
179 studies on the registry are indexed under Lymphoma, Extranodal NK-T-Cell; 32 are open to participants now.
This study's planned enrollment of 24 is below the median of 34 across 161 interventional studies indexed under Lymphoma, Extranodal NK-T-Cell.
Browse Lymphoma, Extranodal NK-T-Cell studies →Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 173 studies on the registry; 105 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Disease diagnosis and status:
Disease types include but are not limited to:
NK/T-cell lymphoma (NK/TCL); Peripheral T-cell lymphoma (PTCL); Other types.
No partial remission (PR) after ≥4 cycles of standard therapy; No complete remission (CR) after ≥6 cycles of therapy; Failure to achieve CR after autologous hematopoietic stem cell transplantation; If best response is progressive disease (PD) or treatment is discontinued due to PD, no minimum cycle requirement applies.
Prior treatment requirements:
a) For relapsed/refractory PTCL or NK/TCL, patients must have received at least one prior line of systemic therapy. For relapsed/refractory NK/TCL, patients must have received an asparaginase-containing regimen (patients with stage I/II nasal NK/TCL according to the CA staging system must have also received radiotherapy).
Measurable disease: At least one measurable lesion according to the 2014 Lymphoma Response Evaluation Criteria:
Adequate organ function, defined as:
Contraception requirements:
Exclusion Criteria:
Subjects meeting any of the following conditions will not be eligible for enrollment:
History of other malignancies, except for:
Severe organ dysfunction, including:
NYHA class IV cardiac function; Child-Pugh class C liver function; Creatinine clearance \<60 mL/min (by Cockcroft-Gault formula); Baseline oxygen saturation \<92%.
Known active infections or positive screening results for:
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
Dose-Limiting Toxicity (DLT)
To evaluate the incidence of dose-limiting toxicities (DLTs) of anti-EBV TCR-T cell injection in subjects with relapsed/refractory EBV-positive HLA-A11:01 lymphoma.
Time frame: treatment cycle (Day 1 to Day 28)
Maximum Tolerated Dose (MTD)
Determination of the maximum tolerated dose of anti-EBV TCR-T cell injection.
Time frame: From Day 1 of treatment until the end of the dose-escalation phase
Recommended Phase 2 Dose (RP2D)
Determination of the recommended dose for the expansion study based on safety, tolerability, and MTD.
Time frame: At the completion of the dose-escalation phase
Expansion and persistence of EBV TCR-T cells
To evaluate the in vivo expansion and persistence of anti-EBV TCR-T cells after infusion
Time frame: From Day 1 of infusion up to 24 months
EBV DNA copies in peripheral blood
To evaluate the EBV DNA copy number in peripheral blood after infusion of anti-EBV TCR-T cells.
Time frame: From Day 1 of infusion up to 24 months
Changes in T-cell subsets in peripheral blood
To evaluate the changes in peripheral blood T-cell subsets after infusion of anti-EBV TCR-T cells.
Time frame: From Day 1 of infusion up to 24 months
Objective Response Rate (ORR)
Proportion of subjects achieving complete response (CR) or partial response (PR) following treatment with anti-EBV TCR-T cells.
Time frame: At 3 months and 6 months after infusion
Duration of Response (DOR)
Duration of response in subjects with relapsed/refractory EBV-positive lymphoma treated with anti-EBV TCR-T cells.
Time frame: From the first documented response (CR or PR) until disease progression/relapse or death, up to 24 months
Progression-Free Survival (PFS)
Progression-free survival following anti-EBV TCR-T cell treatment.
Time frame: From infusion until documented disease progression or death, up to 24 months
Overall Survival (OS)
Overall survival following anti-EBV TCR-T cell treatment.
Time frame: From infusion until death from any cause, up to 24 months
Pharmacokinetic (PK) parameters
Maximum concentration (Cmax), time to maximum concentration (Tmax), and area under the curve (AUC0-28d) of anti-EBV TCR-T cells in peripheral blood.
Time frame: From Day 1 to Day 28 after infusion
Pharmacodynamic (PD) parameters
plasma cytokine levels at multiple time points after infusion.
Time frame: From Day 1 of infusion up to 24 months
Plan to share: Undecided
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Lymphoma, Extranodal NK-T-Cell→
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine