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Drug Highest PhasePhase 1 |
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PD-1基因编辑T细胞注射液治疗晚期非小细胞肺癌的单臂、开放、前瞻性I期临床研究
[Translation] A single-arm, open, prospective phase I clinical study of PD-1 gene-edited T cell injection in the treatment of advanced non-small cell lung cancer
(1)主要目的:评价晚期非小细胞肺癌中使用PD-1基因编辑T细胞注射液(PD-1-KO-T细胞注射液)自体回输的安全性和耐受性;(2)次要目的:初步评价PD-1基因编辑T细胞注射液(PD-1-KO-T细胞注射液)自体回输后的疗效;(3)探索性目的:免疫学指标及生物标记物的变化;治疗细胞体内追踪,并探索治疗细胞在自体内发挥作用的机制。
[Translation] (1) Primary objective: To evaluate the safety and tolerability of autologous infusion of PD-1 gene-edited T cell injection (PD-1-KO-T cell injection) in advanced non-small cell lung cancer; (2) Secondary objective: To preliminarily evaluate the efficacy of autologous infusion of PD-1 gene-edited T cell injection (PD-1-KO-T cell injection); (3) Exploratory objective: Changes in immunological indicators and biomarkers; In vivo tracking of therapeutic cells, and exploration of the mechanism by which therapeutic cells exert their effects in the body.
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