[Translation] A clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of QHRD102 in the treatment of patients with relapsed or refractory acute lymphoblastic leukemia and extranodal NK/T-cell lymphoma
主要研究目的:
? 评价QHRD102注射液剂量递增在复发或难治性急性淋巴细胞白血病(ALL)及结外NK/T细胞淋巴瘤(ENKTL)患者的安全性、耐受性,以确定最大耐受剂量(MTD),剂量限制性毒性(DLT);
? 研究QHRD102注射液的药代动力学(PK)特征及药效学(PD)特征。
次要研究目的:
? 研究QHRD102注射液的免疫原性;
? 评估QHRD102注射液治疗复发或难治性ALL及ENKTL的初步疗效。
[Translation] Main study objectives:
? To evaluate the safety and tolerability of QHRD102 injection in patients with relapsed or refractory acute lymphoblastic leukemia (ALL) and extranodal NK/T-cell lymphoma (ENKTL) to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT);
? To study the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of QHRD102 injection.
Secondary study objectives:
? To study the immunogenicity of QHRD102 injection;
? To evaluate the preliminary efficacy of QHRD102 injection in the treatment of relapsed or refractory ALL and ENKTL.