TAA06注射液治疗复发/难治神经母细胞瘤患者的开放标签、剂量递增、剂量扩展的I期临床研究
[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.
PA3-17注射液治疗成人复发/难治性CD7阳性血液淋巴系统恶性肿瘤患者的开放标签、剂量递增的I期临床研究
[Translation] An open-label, dose-escalation phase I clinical study of PA3-17 injection in the treatment of adult patients with relapsed/refractory CD7-positive hematolymphoid malignancies
主要目的: 评价PA3-17注射液治疗成人复发/难治性CD7阳性血液淋巴系统恶性肿瘤受试者的安全性和耐受性。
次要目的:
1. 评价PA3-17注射液给药后靶向CD7嵌合抗原受体T细胞在体内的扩增及持续情况;
2. 评价PA3-17注射液给药后外周血中CD7阳性细胞的含量;
3. 初步评价PA3-17注射液治疗成人复发/难治性CD7阳性血液淋巴系统恶性肿瘤受试者的有效性;
4. 评价PA3-17注射液的免疫原性;
5. 探索II期阶段的临床适用剂量。
[Translation] Primary objective: To evaluate the safety and tolerability of PA3-17 injection in the treatment of adult subjects with relapsed/refractory CD7-positive hematolymphatic malignancies.
Secondary objectives:
1. To evaluate the expansion and persistence of CD7-targeted chimeric antigen receptor T cells in vivo after PA3-17 injection;
2. To evaluate the content of CD7-positive cells in peripheral blood after PA3-17 injection;
3. To preliminarily evaluate the effectiveness of PA3-17 injection in the treatment of adult subjects with relapsed/refractory CD7-positive hematolymphatic malignancies;
4. To evaluate the immunogenicity of PA3-17 injection;
5. To explore the clinically applicable dose in Phase II.
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