[Translation] A Phase I clinical study of the safety, tolerability and preliminary efficacy of CRTE7A2-01 TCR-T cell injection in the treatment of HPV16-positive HLA-A*02:01-positive advanced solid tumors (cervical cancer, head and neck cancer, anal cancer and other tumor types)
主要目的:
评价CRTE7A2-01 TCR-T细胞注射液的安全性和耐受性;
次要目的:
评价CRTE7A2-01 TCR-T细胞注射液的有效性;
探索性目的:
评价CRTE7A2-01 TCR-T细胞注射液在受试者体内的扩增、存活、分布等动力学特性;
评价CRTE7A2-01 TCR-T细胞注射液在受试者中的免疫原性;
监测慢病毒载体在TCR-T中的整合位点和复制型慢病毒(RCL);
评价T细胞免疫相关基因缺失或者失活突变比例对CRTE7A2-01 TCR-T细胞注射液有效性的影响;
评价CRTE7A2-01 TCR-T细胞注射液输注至受试者体内后的生物学活性;
分析CRTE7A2-01 TCR-T细胞注射液输注后受试者外周血T细胞免疫组库的变化,评价对受试者外周血T细胞克隆多样性的影响;
[Translation] Main purpose:
Evaluate the safety and tolerability of CRTE7A2-01 TCR-T cell injection;
Secondary purpose:
Evaluate the effectiveness of CRTE7A2-01 TCR-T cell injection;
Exploratory purpose:
Evaluate the kinetic characteristics of CRTE7A2-01 TCR-T cell injection in subjects, such as expansion, survival, and distribution;
Evaluate the immunogenicity of CRTE7A2-01 TCR-T cell injection in subjects;
Monitor the integration site of lentiviral vectors in TCR-T and replicative lentivirus (RCL);
Evaluate the effect of T cell immune-related gene deletion or inactivation mutation ratio on the effectiveness of CRTE7A2-01 TCR-T cell injection;
Evaluate the biological activity of CRTE7A2-01 TCR-T cell injection after infusion into subjects;
Analyze the changes in the peripheral blood T cell immune repertoire of subjects after infusion of CRTE7A2-01 TCR-T cell injection, and evaluate the effect on the clonal diversity of peripheral blood T cells in subjects;