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MechanismMAGEA4 modulators |
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Inactive Indication- |
Drug Highest PhasePreclinical |
First Approval Ctry. / Loc.- |
First Approval Date- |
HRYZ-T101 治疗 HPV18 阳性恶性实体瘤的Ⅰ期开放临床研究
[Translation] Phase I open clinical study of HRYZ-T101 in the treatment of HPV18-positive malignant solid tumors
主要目的:评价HRYZ-T101注射液治疗既往经标准治疗失败的复发或转移性、且HPV18阳性实体瘤患者的安全性和耐受性,并确定II期临床试验的推荐给药剂量(RP2D)。次要目的:(1)初步探索HRYZ-T101注射液治疗既往经标准治疗失败的复发或转移性、且HPV18阳性实体瘤患者的临床有效性;(2)评价HRYZ-T101注射液给药后,TCR-T细胞在受试者体内活化、扩增及存续情况;(3)评价HRYZ-T101注射液给药后外周血细胞因子水平及炎性标志物变化。
[Translation] Primary objectives: To evaluate the safety and tolerability of HRYZ-T101 injection in the treatment of patients with recurrent or metastatic HPV18-positive solid tumors who have failed standard treatment, and to determine the recommended dose (RP2D) for the Phase II clinical trial. Secondary objectives: (1) To preliminarily explore the clinical efficacy of HRYZ-T101 injection in the treatment of patients with recurrent or metastatic HPV18-positive solid tumors who have failed standard treatment; (2) To evaluate the activation, expansion and survival of TCR-T cells in the subjects after administration of HRYZ-T101 injection; (3) To evaluate the changes in peripheral blood cytokine levels and inflammatory markers after administration of HRYZ-T101 injection.
100 Clinical Results associated with HRYZ (Guangzhou) Biotech Co., Ltd.
0 Patents (Medical) associated with HRYZ (Guangzhou) Biotech Co., Ltd.
100 Deals associated with HRYZ (Guangzhou) Biotech Co., Ltd.
100 Translational Medicine associated with HRYZ (Guangzhou) Biotech Co., Ltd.