[Translation] An open-label, dose-escalation, and dose-expansion phase I clinical study of TAA06 injection in patients with relapsed/refractory neuroblastoma
主要目的:1、评估 TAA06 注射液用于复发/难治神经母细胞瘤受试者的最大耐受剂量(MTD)和/或 2 期推荐剂量(RP2D);2、评估 TAA06 注射液用于复发/难治神经母细胞瘤受试者的安全性。次要目的:1、评估 TAA06 注射液用于复发/难治神经母细胞瘤受试者的药代动力学( PK)特征;2、评估 TAA06 注射液用于复发/难治神经母细胞瘤受试者的初步抗肿瘤活性;3、评估 TAA06 注射液用于复发/难治神经母细胞瘤受试者的免疫原性。探索性目的:1、评估肿瘤组织 B7-H3 阳性率;2、评估慢病毒基因插入整合位点的情况;3、探索性应用国际神经母细胞瘤疗效反应评估标准( INRC)进行疗效评估。
[Translation] Primary objectives: 1. Evaluate the maximum tolerated dose (MTD) and/or phase 2 recommended dose (RP2D) of TAA06 injection for subjects with relapsed/refractory neuroblastoma; 2. Evaluate the safety of TAA06 injection for subjects with relapsed/refractory neuroblastoma. Secondary objectives: 1. Evaluate the pharmacokinetic (PK) characteristics of TAA06 injection for subjects with relapsed/refractory neuroblastoma; 2. Evaluate the preliminary anti-tumor activity of TAA06 injection for subjects with relapsed/refractory neuroblastoma; 3. Evaluate the immunogenicity of TAA06 injection for subjects with relapsed/refractory neuroblastoma. Exploratory objectives: 1. Evaluate the B7-H3 positivity rate in tumor tissues; 2. Evaluate the insertion and integration sites of lentiviral genes; 3. Exploratory application of the International Neuroblastoma Response Evaluation Criteria (INRC) for efficacy evaluation.