[Translation] An open, multicenter phase I clinical study to evaluate the safety, tolerability and preliminary efficacy of IBR900 cell injection in the treatment of relapsed/refractory CD20-positive B-cell non-Hodgkin's lymphoma
Ia期主要研究目的
1)评估复发/难治CD20阳性B细胞非霍奇金淋巴瘤受试者接受研究药物治疗的安全性和耐受性。
2)确定复发/难治CD20阳性B细胞非霍奇金淋巴瘤受试者接受研究药物治疗的推荐的II期剂量。
Ia期次要研究目的
1)初步评估复发/难治CD20阳性B细胞非霍奇金淋巴瘤受试者接受研究药物治疗的疗效。
2)IBR900细胞注射液在复发/难治CD20阳性B细胞非霍奇金淋巴瘤受试者中的药代动力学(PK)特征。
[Translation] Phase Ia main study objectives
1) To evaluate the safety and tolerability of the study drug in subjects with relapsed/refractory CD20-positive B-cell non-Hodgkin's lymphoma.
2) To determine the recommended Phase II dose for subjects with relapsed/refractory CD20-positive B-cell non-Hodgkin's lymphoma to receive the study drug.
Phase Ia secondary study objectives
1) To preliminarily evaluate the efficacy of the study drug in subjects with relapsed/refractory CD20-positive B-cell non-Hodgkin's lymphoma.
2) Pharmacokinetic (PK) characteristics of IBR900 cell injection in subjects with relapsed/refractory CD20-positive B-cell non-Hodgkin's lymphoma.