[Translation] A multicenter, randomized, controlled, open-label phase II clinical study of autologous tumor-infiltrating lymphocyte injection (GT101 injection) in the treatment of recurrent or metastatic cervical cancer
主要研究目的
评价GT101注射液在转移性或复发的宫颈癌治疗中的有效性。
次要研究目的
评价GT101注射液在转移性或复发的宫颈癌治疗中的安全性;
监测GT101注射液在转移性或复发的宫颈癌治疗中的药代动力学。
探索性研究目的
探索回输后外周血中淋巴细胞组分、T细胞表型的变化,通过TCR测序进行产品相关TIL克隆的追踪,来观察可能与GT101注射液安全性和有效性相关的免疫细胞变化。
[Translation] Main study objectives
To evaluate the effectiveness of GT101 injection in the treatment of metastatic or recurrent cervical cancer.
Secondary study objectives
To evaluate the safety of GT101 injection in the treatment of metastatic or recurrent cervical cancer;
To monitor the pharmacokinetics of GT101 injection in the treatment of metastatic or recurrent cervical cancer.
Exploratory study objectives
To explore the changes in lymphocyte components and T cell phenotypes in peripheral blood after reinfusion, and to track product-related TIL clones through TCR sequencing to observe changes in immune cells that may be related to the safety and effectiveness of GT101 injection.