Target- |
MechanismImmunologic cytotoxicity [+1] |
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Inactive Indication- |
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target- |
MechanismImmunologic cytotoxicity [+1] |
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Inactive Indication- |
Drug Highest PhasePhase 1/2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target- |
Mechanism- |
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Inactive Indication- |
Drug Highest PhaseEarly Phase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
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;
[Translation] Main research purposes:
To evaluate the safety and tolerability of GT101 injection in the treatment of metastatic or recurrent solid tumors.
Secondary research purposes:
To evaluate the efficacy of GT101 injection in the treatment of metastatic or recurrent solid tumors;
自体肿瘤浸润淋巴细胞注射液(GT201)治疗晚期实体瘤的单臂I/II 期临床研究
[Translation] Single-arm phase I/II clinical study of autologous tumor-infiltrating lymphocyte injection (GT201) in the treatment of advanced solid tumors
Ⅰ期试验:
主要研究目的
评价GT201 注射液在复发或转移性的实体瘤治疗中的安全性和耐受性。
次要研究目的
评价GT201 注射液在复发或转移性的实体瘤治疗中的有效性;
监测GT201 注射液在复发或转移性的实体瘤治疗中的药代动力学:回输后受试者体内不同时间点外周血中CD3+T 细胞计数以及基因载体WPRE 拷贝数与GT201 注射液有效性的相关性。T 细胞功能相关的细胞因子如TNF-α,IFN-γ,IL-6。
[Translation] Phase I trial:
Main research purpose
To evaluate the safety and tolerability of GT201 injection in the treatment of recurrent or metastatic solid tumors.
Secondary research purpose
To evaluate the effectiveness of GT201 injection in the treatment of recurrent or metastatic solid tumors;
Monitor the pharmacokinetics of GT201 injection in the treatment of recurrent or metastatic solid tumors: CD3+T cell counts in peripheral blood of subjects at different time points after reinfusion and the copy number of gene vector WPRE and the effectiveness of GT201 injection correlation. Cytokines related to T cell function such as TNF-α, IFN-γ, IL-6.
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 multi-center, 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 research purpose
To evaluate the effectiveness of GT101 injection in the treatment of metastatic or recurrent cervical cancer.
Secondary research purpose
To evaluate the safety of GT101 injection in the treatment of metastatic or recurrent cervical cancer;
Monitor the pharmacokinetics of GT101 injection in the treatment of metastatic or recurrent cervical cancer.
exploratory research purpose
Explore changes in lymphocyte components and T cell phenotypes in peripheral blood after reinfusion, and 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.
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