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Clinical Trials associated with HR-010 (Hrain Biotechnology)评估抗人CD70 T细胞注射液在晚期/转移性肾癌受试者中的安全性及耐受性的Ⅰ期临床研究
[Translation] A Phase I clinical study evaluating the safety and tolerability of anti-human CD70 T cell injection in patients with advanced/metastatic renal cell carcinoma.
主要研究目的:评价抗人CD70 T细胞注射液用于治疗晚期/转移性肾癌受试者的安全性和耐受性。
次要研究目的:
(1) 评价抗人CD70 T细胞注射液回输后抗人CD70 T细胞在体内扩增及存续情况;
(2) 初步评价抗人CD70 T细胞治疗晚期/转移性肾癌受试者回输后的客观缓解率(ORR);
(3) 评价抗人CD70 T细胞注射液治疗晚期/转移性肾癌受试者的总体缓解时间(DOR);
(4) 评价抗人CD70 T细胞注射液治疗晚期/转移性肾癌受试者的无进展生存期(PFS);
(5) 评价抗人CD70 T细胞注射液治疗治疗晚期/转移性肾癌受试者的总生存期(OS);
(6) 评价抗人CD70 T细胞注射液的免疫原性。
[Translation] Primary objective: To evaluate the safety and tolerability of anti-human CD70 T cell injection in the treatment of patients with advanced/metastatic renal cell carcinoma.
Secondary objectives:
(1) To evaluate the in vivo expansion and survival of anti-human CD70 T cells after infusion of anti-human CD70 T cell injection;
(2) To preliminarily evaluate the objective response rate (ORR) after infusion of anti-human CD70 T cell therapy in patients with advanced/metastatic renal cell carcinoma;
(3) To evaluate the duration of overall response (DOR) in patients with advanced/metastatic renal cell carcinoma treated with anti-human CD70 T cell injection;
(4) To evaluate the progression-free survival (PFS) in patients with advanced/metastatic renal cell carcinoma treated with anti-human CD70 T cell injection;
(5) To evaluate the overall survival (OS) in patients with advanced/metastatic renal cell carcinoma treated with anti-human CD70 T cell injection;
(6) To evaluate the immunogenicity of anti-human CD70 T cell injection.
100 Clinical Results associated with HR-010 (Hrain Biotechnology)
100 Translational Medicine associated with HR-010 (Hrain Biotechnology)
100 Patents (Medical) associated with HR-010 (Hrain Biotechnology)
100 Deals associated with HR-010 (Hrain Biotechnology)