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Clinical Trials associated with Neoantigen targeting T cells Suspension for Intravenous Infusion(Genoimmune Therapeutics) / Not yet recruitingPhase 1 评价个性化靶向新生抗原自体免疫T细胞注射液(Neo-T注射液)治疗晚期实体肿瘤的安全性、耐受性及初步疗效的Ia期临床研究
[Translation] A phase Ia clinical study to evaluate the safety, tolerability and preliminary efficacy of personalized neoantigen-targeted autologous immune T cell injection (Neo-T injection) in the treatment of advanced solid tumors
评价Neo-T注射液单药治疗的安全性与有效性
主要目的:
1.评价晚期实体瘤受试者接受Neo-T注射液的安全性和耐受性;
2.探索最大耐受剂量(MTD)或后期临床研究推荐剂量。
次要目的:
通过RECIST1.1标准初步评价Neo-T注射液的有效性,通过ORR、PFS、DOR、DCR、OS进行评估;
探索性研究目的:
1.通过iRECIST标准评价Neo-T注射液的初步疗效;
2.开展Neo-T注射液体内过程研究,初步描述细胞在体内的活力及相关的生物学功能。
[Translation] Evaluate the safety and efficacy of Neo-T injection monotherapy
Main purpose:
1. Evaluate the safety and tolerability of Neo-T injection in subjects with advanced solid tumors;
2. Explore the maximum tolerated dose (MTD) or the recommended dose for later clinical studies.
Secondary purpose:
Preliminary evaluation of the efficacy of Neo-T injection by RECIST1.1 standard, and evaluation by ORR, PFS, DOR, DCR, OS;
Purpose of exploratory study:
1. Evaluate the preliminary efficacy of Neo-T injection by iRECIST standard;
2. Conduct a study on the in vivo process of Neo-T injection to preliminarily describe the viability of cells in vivo and related biological functions.
100 Clinical Results associated with Neoantigen targeting T cells Suspension for Intravenous Infusion(Genoimmune Therapeutics)
100 Translational Medicine associated with Neoantigen targeting T cells Suspension for Intravenous Infusion(Genoimmune Therapeutics)
100 Patents (Medical) associated with Neoantigen targeting T cells Suspension for Intravenous Infusion(Genoimmune Therapeutics)
100 Deals associated with Neoantigen targeting T cells Suspension for Intravenous Infusion(Genoimmune Therapeutics)