[Translation] An open-label, single-arm, multi-cohort phase IIa clinical study to evaluate the safety and efficacy of Tafasitamab combined with lenalidomide and orelabrutinib in the treatment of patients with relapsed or refractory non-Hodgkin's lymphoma
1. 主要目的:评估Tafa联合Len和奥布替尼治疗复发或难治性非霍奇金淋巴瘤患者的疗效。
2. 次要目的:1)评估Tafa联合Len和奥布替尼治疗复发或难治性非霍奇金淋巴瘤患者的其它疗效指标。2)评估Tafa联合Len和奥布替尼治疗复发或难治性非霍奇金淋巴瘤患者的安全性。
3. 其他目的:1)探索Tafa和奥布替尼的药代动力学(PK)特征。2)评估Tafa的免疫原性。
[Translation] 1. Primary objective: To evaluate the efficacy of Tafa combined with Len and orelabrutinib in the treatment of patients with relapsed or refractory non-Hodgkin's lymphoma.
2. Secondary objectives: 1) To evaluate other efficacy indicators of Tafa combined with Len and orelabrutinib in the treatment of patients with relapsed or refractory non-Hodgkin's lymphoma. 2) To evaluate the safety of Tafa combined with Len and orelabrutinib in the treatment of patients with relapsed or refractory non-Hodgkin's lymphoma.
3. Other objectives: 1) To explore the pharmacokinetic (PK) characteristics of Tafa and orelabrutinib. 2) To evaluate the immunogenicity of Tafa.