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TC-N201注射液治疗HLA-A2表达合并NY-ESO-1阳性的标准治疗失败的复发或者转移性实体瘤的I期临床研究
[Translation] Phase I clinical study of TC-N201 injection in the treatment of recurrent or metastatic solid tumors with HLA-A2 expression and NY-ESO-1 positive standard treatment failure
评价TC-N201 注射液治疗 HLA-A2 表达合并 NY-ESO-1 阳性的标准治疗失败的复发或者转移性实体瘤的安全性和耐受性,并确定 II 期临床研究的推荐给药剂量(Recommend PhaseII Dose,RP2D)
[Translation] To evaluate the safety and tolerability of TC-N201 injection in the treatment of recurrent or metastatic solid tumors with HLA-A2 expression and NY-ESO-1 positive standard treatment failure, and to determine the recommended dosage for phase II clinical research (Recommended Phase II Dose, RP2D)
HV-101注射液治疗既往治疗失败的复发或者转移性实体瘤患者的安全性、耐受性和初步有效性的Ⅰ期临床研究
[Translation] A phase I clinical study on the safety, tolerability and preliminary efficacy of HV-101 injection in the treatment of patients with recurrent or metastatic solid tumors who failed previous treatment
主要目的:评价HV-101注射液在既往治疗失败的复发或者转移性实体瘤患者中的安全性和耐受性。
次要目的:初步评估HV-101注射液在既往治疗失败的复发或者转移性实体瘤患者中的有效性。
[Translation] Main objective: To evaluate the safety and tolerability of HV-101 injection in patients with recurrent or metastatic solid tumors who failed previous treatment.
Secondary objective: To preliminarily evaluate the effectiveness of HV-101 injection in patients with recurrent or metastatic solid tumors who failed previous treatment.
TC-E202注射液治疗HPV16阳性的既往治疗失败的复发或者转移性宫颈癌的Ⅰ期临床研究
[Translation] Phase I clinical study of TC-E202 injection in the treatment of HPV16-positive recurrent or metastatic cervical cancer after previous treatment failure
主要目的:
评价TC-E202注射液治疗HPV16阳性的既往治疗失败的复发或者转移性宫颈癌的安全性和耐受性,并确定II期临床研究的推荐给药剂量(RPIID)。
次要目的:
1.初步探索TC-E202注射液治疗HPV16阳性的既往治疗失败的复发或者转移性宫颈癌的临床有效性;
2.评价TC-E202注射液给药后,工程化TCR-T细胞在受试者体内活化、扩增及存续情况以及抗PD-1单链抗体的分泌表达情况;
3.评价TC-E202注射液给药后,各时间点外周血细胞因子的浓度水平以及内源性T细胞克隆分布变化,以及生物标记物(SCC、CEA、CA125、CA199)变化情况,探索这些生物标志物与疗效及安全性的相关性。
[Translation] main purpose:
To evaluate the safety and tolerability of TC-E202 injection in the treatment of HPV16-positive recurrent or metastatic cervical cancer that has failed previous treatment, and to determine the recommended dose (RPIID) for phase II clinical studies.
Secondary purpose:
1. Preliminarily explore the clinical efficacy of TC-E202 injection in the treatment of HPV16-positive recurrent or metastatic cervical cancer that has failed previous treatment;
2. To evaluate the activation, expansion and survival of engineered TCR-T cells in subjects and the secretion and expression of anti-PD-1 single-chain antibody after administration of TC-E202 injection;
3. After TC-E202 injection was administered, the concentration levels of peripheral blood cytokines and the distribution of endogenous T cell clones at each time point were evaluated, as well as the changes of biomarkers (SCC, CEA, CA125, CA199), and explored these biological Correlation of markers with efficacy and safety.
100 Clinical Results associated with Guangdong TCRCure Biopharma Technology Co., Ltd.
0 Patents (Medical) associated with Guangdong TCRCure Biopharma Technology Co., Ltd.
100 Deals associated with Guangdong TCRCure Biopharma Technology Co., Ltd.
100 Translational Medicine associated with Guangdong TCRCure Biopharma Technology Co., Ltd.