OncoMatch/Clinical Trials/NCT07162012
Safety and Efficacy of Anti-EBV Autologous TCR-T Cell Injection in Relapsed/Refractory EBV-Positive Lymphoma
Is NCT07162012 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies EBV TCR-T for nk/t-cell lymphoma.
Treatment: EBV TCR-T — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Biomarker criteria
Required: HLA-A 11:01 genotype
HLA genotype at locus A is 11:01
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — relapsed/refractory PTCL or NK/TCL
patients must have received at least one prior line of systemic therapy
Must have received: asparaginase-containing regimen — relapsed/refractory NK/TCL
patients must have received an asparaginase-containing regimen
Must have received: radiotherapy — stage I/II nasal NK/TCL (CA staging system)
patients with stage I/II nasal NK/TCL according to the CA staging system must have also received radiotherapy
Cannot have received: anti-cancer 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
Lab requirements
Blood counts
absolute neutrophil count ≥1×10⁹/L; hemoglobin ≥70 g/L; platelet count ≥50×10⁹/L
Kidney function
serum creatinine ≤1.5× ULN; creatinine clearance ≥60 mL/min (by Cockcroft-Gault formula)
Liver function
ALT and AST ≤ 3 × ULN, TBIL ≤ 1.5 × ULN (except when liver function abnormalities are attributable to the underlying disease)
Cardiac function
LVEF ≥50%; NYHA class IV cardiac function excluded
Adequate organ function, defined as: Hematologic: absolute neutrophil count ≥1×10⁹/L; hemoglobin ≥70 g/L; platelet count ≥50×10⁹/L; Hepatic: ALT and AST ≤ 3 × ULN, TBIL ≤ 1.5 × ULN (except when liver function abnormalities are attributable to the underlying disease); Renal: serum creatinine ≤1.5× ULN; Cardiac: LVEF ≥50%; Coagulation: fibrinogen ≥1.0 g/L; APTT ≤1.5× ULN; PT ≤1.5× ULN. 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% [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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