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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date05 May 1992 |
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Inactive Indication- |
Drug Highest PhaseClinical |
First Approval Ctry. / Loc.- |
First Approval Date- |
自体肿瘤浸润淋巴细胞注射液(GT101注射液)治疗复发或转移性宫颈癌的多中心、随机对照、开放性Ⅱ期临床研究
[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
Ⅱ期试验:
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] Phase II trial:
Main study purpose
To evaluate the effectiveness of GT101 injection in the treatment of metastatic or recurrent cervical cancer.
Secondary study purpose
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 purpose
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.
自体肿瘤浸润淋巴细胞注射液(GT101注射液)治疗复发或转移性宫颈癌的多中心、随机对照、开放性Ⅱ期临床研究
[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.
/ Active, not recruitingPhase 1 GT101注射液治疗转移或复发的实体瘤的单臂I期临床研究
[Translation] A single-arm phase I clinical study of GT101 injection in the treatment of metastatic or recurrent solid tumors
主要研究目的:
评价GT101注射液在转移或复发的实体瘤治疗中的安全性和耐受性。
次要研究目的:
评价GT101注射液在转移或复发的实体瘤治疗中的有效性;
监测GT101注射液在转移或复发的实体瘤治疗中的药效及药代动力学:回输TIL细胞在受试者体内的存续时间、扩增状况以及与GT101注射液有效性的相关性。
[Translation] Main study objectives:
To evaluate the safety and tolerability of GT101 injection in the treatment of metastatic or recurrent solid tumors.
Secondary study objectives:
To evaluate the effectiveness of GT101 injection in the treatment of metastatic or recurrent solid tumors;
To monitor the efficacy and pharmacokinetics of GT101 injection in the treatment of metastatic or recurrent solid tumors: the survival time and expansion status of the reinfused TIL cells in the subjects and their correlation with the effectiveness of GT101 injection.
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