[Translation] Safety and preliminary efficacy of autologous T cell injection targeting CD99 chimeric antigen receptor gene modification in patients with relapsed/refractory CD99+ bone or soft tissue sarcoma, an open, phase I clinical study
主要目的:
评价靶向CD99嵌合抗原受体基因修饰的自体T细胞注射液治疗复发/难治性CD99+骨或软组织肉瘤患者的安全性和耐受性。
次要目的:
评价靶向CD99嵌合抗原受体基因修饰的自体T细胞注射液给药后的药代动力学特征;
评价靶向CD99嵌合抗原受体基因修饰的自体T细胞注射液给药后的药效动力学特征;
评价靶向CD99嵌合抗原受体基因修饰的自体T细胞注射液的免疫原性;
评价靶向CD99嵌合抗原受体基因修饰的自体T细胞注射液在复发/难治性CD99+骨或软组织肉瘤的初步疗效;
探索Ⅱ期临床研究阶段的临床适用剂量。
[Translation] Main purpose:
To evaluate the safety and tolerability of autologous T cell injection targeting CD99 chimeric antigen receptor gene modification in the treatment of patients with relapsed/refractory CD99+ bone or soft tissue sarcoma.
Secondary purpose:
To evaluate the pharmacokinetic characteristics of autologous T cell injection targeting CD99 chimeric antigen receptor gene modification after administration;
To evaluate the pharmacodynamic characteristics of autologous T cell injection targeting CD99 chimeric antigen receptor gene modification after administration;
To evaluate the immunogenicity of autologous T cell injection targeting CD99 chimeric antigen receptor gene modification;
To evaluate the preliminary efficacy of autologous T cell injection targeting CD99 chimeric antigen receptor gene modification in relapsed/refractory CD99+ bone or soft tissue sarcoma;
To explore the clinically applicable dose in the phase II clinical study.