RecruitingEarly Phase 1NCT07162012

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

The Safety and Efficacy of Anti-EBV Autologous TCR-T Cell Injection for Treating Relapsed/Refractory EBV-positive Lymphoma Patients With HLA-A11:01


Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

24 participants

Start Date

Sep 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of immune cell therapy (using your own modified T-cells, called TCR-T cells) against lymphoma caused by the Epstein-Barr virus (EBV) — the same virus that causes mono. It targets people whose lymphoma has come back or stopped responding to previous treatments. **You may be eligible if...** - You are 18 to 70 years old - You have been confirmed to have EBV-positive lymphoma (including NK/T-cell or peripheral T-cell lymphoma) - Your lymphoma has relapsed (come back) or is refractory (not responding to treatment) - Your blood tests show EBV viral activity - You have a specific genetic marker (HLA-A 11:01) **You may NOT be eligible if...** - You have had a prior stem cell transplant recently - You have serious organ problems or active infections - You do not have the required genetic marker Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEBV 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


Locations(1)

Shanghai General Hospital

Shanghai, China

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NCT07162012


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