[Translation] An I/O study evaluating the safety and efficacy of a trispecific T-cell-mediated antibody (1A46) in adult subjects with R/R CD20 and/or CD19-positive B-cell non-Hodgkin's lymphoma (B-NHL) Phase II, open-label, first-in-human single-arm study
I期部分
主要目的:
评价1A46在CD20和/或CD19阳性的R/R B-NHL受试者中的安全性、耐受性、最大耐受剂量(MTD)/推荐的II期研究剂量(RP2D)。
II期部分
主要目的:
评价1A46在CD20和/或CD19阳性R/R B-NHL受试者中的有效性。
在CD20和/或CD19阳性R/R B-NHL受试者中的药代动力学(PK)特征。评价1A46在CD20和/或CD19阳性R/R B-NHL受试者中的药效动力学(PD)作用。评价1A46在CD20和/或CD19阳性R/R B-NHL受试者中初步的抗肿瘤活性。评价1A46在CD20和/或CD19阳性R/R B-NHL受试者中的免疫原性。
探索性目的:探索1A46暴露量与B细胞耗竭、疗效和安全性的关系。初步探索药效学指标与疗效的关系。探索抗药抗体的产生对疗效和安全性的影响。
II期部分
主要目的:评价1A46在CD20和/或CD19阳性R/R B-NHL受试者中的有效性。
[Translation] Part I
main purpose:
To evaluate the safety, tolerability, maximum tolerated dose (MTD)/recommended phase II study dose (RP2D) of 1A46 in CD20 and/or CD19 positive R/R B-NHL subjects.
Phase II part
main purpose:
To evaluate the efficacy of 1A46 in subjects with CD20 and/or CD19 positive R/R B-NHL.
Pharmacokinetic (PK) profiles in CD20 and/or CD19 positive R/R B-NHL subjects. To evaluate the pharmacodynamic (PD) effect of 1A46 in CD20 and/or CD19 positive R/R B-NHL subjects. To evaluate the preliminary antitumor activity of 1A46 in CD20 and/or CD19 positive R/R B-NHL subjects. To evaluate the immunogenicity of 1A46 in CD20 and/or CD19 positive R/R B-NHL subjects.
Exploratory purpose: To explore the relationship between 1A46 exposure and B cell depletion, efficacy and safety. Preliminary exploration of the relationship between pharmacodynamic indicators and curative effect. Explore the impact of anti-drug antibody production on efficacy and safety.
Phase II part
Main objective: To evaluate the efficacy of 1A46 in CD20 and/or CD19 positive R/R B-NHL subjects.