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Early Phase 1RecruitingPriority 4 · Lower priorityNCT07162012

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

ClinicalTrials.gov

Plain-language summary

This trial is testing EBV-specific T cells (immune cells trained to attack Epstein-Barr virus in lymphoma cells) for patients with extranodal NK/T-cell lymphoma (ENKTL) who have been newly diagnosed and have not yet received treatment as well as those whose disease has come back or stopped responding to prior treatment. This is an early Phase 1 trial, which means this is among the first tests of the treatment in patients, focusing on safety and dose. The study looks at both safety and how well the treatment controls the lymphoma. This trial does not currently have sites in the United States. The trial is currently recruiting patients.

Who can join (key eligibility)

  • Age 18 Years to 70 Years years
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

EBV TCR-T (DRUG): 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

  • EBV TCR-T

Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

Learn more

What is ENKTL?

Plain-language overview of ENKTL plus all curated trials for this subtype.

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TrialCompass — Clinical Trial Summary

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

NCT07162012

Phase: Early Phase 1 | Status: Recruiting | Priority: Lower

Plain-language summary

This trial is testing EBV-specific T cells (immune cells trained to attack Epstein-Barr virus in lymphoma cells) for patients with extranodal NK/T-cell lymphoma (ENKTL) who have been newly diagnosed and have not yet received treatment as well as those whose disease has come back or stopped responding to prior treatment. This is an early Phase 1 trial, which means this is among the first tests of the treatment in patients, focusing on safety and dose. The study looks at both safety and how well the treatment controls the lymphoma. This trial does not currently have sites in the United States. The trial is currently recruiting patients.

Who can join

  • Age 18 Years to 70 Years years
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)

What's being tested

EBV TCR-T (DRUG): 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

Drugs / treatments: EBV TCR-T

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 24 patients

Primary endpoint: Dose-Limiting Toxicity (DLT); Maximum Tolerated Dose (MTD); Recommended Phase 2 Dose (RP2D)

Ages: 18 Years to 70 Years

Start date: 2025-09-20 | Est. completion: 2029-09

Locations

0 US sites · 1 total

Contact

Xianmin Song, Doctor | shongxm@139.com | +86 18918029692

Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (OTHER)

Tags

ENKTL · Newly diagnosed · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT07162012

Prepared using TrialCompass (trialcompass.com) on August 3, 2026. For informational purposes only. Always discuss with your healthcare team.