[Translation] Phase I clinical trial of TAEST1901 injection for the treatment of advanced liver cancer or other advanced tumors with HLA-A*02:01 genotype and positive expression of tumor antigen AFP, open, safety and efficacy evaluation
主要目的:
研究TAEST1901治疗基因型为HLA-A*02:01,肿瘤抗原AFP表达为阳性的晚期肝癌或其它晚期肿瘤受试者的安全性和耐受性。 次要目的:
1.研究TAEST1901治疗基因型为HLA-A*02:01,肿瘤抗原AFP表达为阳性的晚期肝癌或其它晚期肿瘤受试者的初步有效性。
2.研究TAEST1901细胞回输人体后的药代动力学(PK)特征、药效动力学(PD)特征,观察其在体内的增殖和持续性,以及对人体免疫学活性的影响。
3.研究TAEST1901治疗前后受试者体内的AFP表达及慢病毒的复制情况。
[Translation] Main purpose:
To study the safety and tolerability of TAEST1901 in the treatment of subjects with advanced liver cancer or other advanced tumors whose genotype is HLA-A*02:01 and whose tumor antigen AFP is positive. Secondary purpose:
1. To study the preliminary effectiveness of TAEST1901 in the treatment of subjects with advanced liver cancer or other advanced tumors whose genotype is HLA-A*02:01 and whose tumor antigen AFP is positive.
2. To study the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of TAEST1901 cells after reinfusion into the human body, and to observe their proliferation and persistence in the body, as well as their effects on human immunological activity.
3. To study the AFP expression in the subjects and the replication of lentivirus before and after TAEST1901 treatment.