In this study, a single-arm, open-labeled clinical trial will be performed to determine the safety and efficacy of EBV TCR-T cells in the treatment of recurrent/metastatic nasopharyngeal carcinoma with positive EBV infection in the Chinese population.
All enrolled subjects will be infused with EBV TCR-T cells. The project which enrolls 27 patients, according to the patient's HLA subtypes will be divided into HLA-A2, HLA-A11, HLA-A24 three groups, 9 patients in each group. Using a dose climbing method, each group will be divided into three dose subgroups. In the first dose subgroup, 5×106/kg TCR-T cells will be returned, and in the second dose subgroup, 1×107/kg TCR-T cells will be returned. The third dose subgroup 5 x 107/kg TCR-T cells will be returned.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
All enrolled subjects will be infused with EBV TCR-T cells. The project which enrolls 27 patients, according to the patient's HLA subtypes will be divided into HLA-A2, HLA-A11, HLA-A24 three groups, 9 patients in each group. Using a dose climbing method, each group will be divided into three dose subgroups. In the first dose subgroup, 5×106/kg TCR-T cells will be returned, and in the second dose subgroup, 1×107/kg TCR-T cells will be returned. The third dose subgroup 5 x 107/kg TCR-T cells will be returned.
Sun Yat-sen Universitty Cancer Center
Guangzhou, Guangdong, China
RECRUITINGTo Determine the Maximum Tolerated Dose of TCR T-cell Therapy
Verify the MTD of LMP2 Antigen-specific TCR T-cell Therapy
Time frame: 2 years
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