Safety and Efficacy of Anti-EBV Autologous TCR-T Cell Injection in Relapsed/Refractory EBV-Positi… (NCT07162012) | Clinical Trial Compass
RecruitingEarly Phase 1
Safety and Efficacy of Anti-EBV Autologous TCR-T Cell Injection in Relapsed/Refractory EBV-Positive Lymphoma
China24 participantsStarted 2025-09-20
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age 18-70 years, male or female.
✓. HLA genotype at locus A is 11:01.
✓. Disease diagnosis and status:
✓. Histologically or cytologically confirmed EBV-positive lymphoma (tumor tissue must be EBER-positive as confirmed by in situ hybridization \[ISH\] or fluorescence in situ hybridization \[FISH\]), with peripheral blood EBV viral load \>10³ copies/mL by quantitative real-time PCR.
✓. Disease types include but are not limited to:
✓. Definition of relapse: appearance of new lesions at the primary site or other sites after achieving complete remission (CR).
✓. Definition of refractory disease (meeting any of the following):
✓. Prior treatment requirements:
Exclusion criteria
✕. History of other malignancies, except for:
✕
What they're measuring
1
Dose-Limiting Toxicity (DLT)
Timeframe: treatment cycle (Day 1 to Day 28)
2
Maximum Tolerated Dose (MTD)
Timeframe: From Day 1 of treatment until the end of the dose-escalation phase
3
Recommended Phase 2 Dose (RP2D)
Timeframe: At the completion of the dose-escalation phase
Trial details
NCT IDNCT07162012
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
✕. Other malignancies considered acceptable by the investigator (must have received curative treatment with no recurrence within the past 5 years).
✕. Recent anti-tumor therapy: less than 4 weeks since last anti-cancer therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy, or local therapy), or less than 2 weeks since palliative radiotherapy.