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Clinical Trials associated with QLP-31907PSB202在既往接受过治疗的复发惰性B细胞恶性肿瘤患者的Ia/Ib期研究
[Translation] Phase Ia/Ib Study of PSB202 in Patients with Previously Treated Relapsed Indolent B-Cell Malignancies
主要目的(Ia期 - 剂量递增): 确定PSB202在既往接受治疗的B细胞恶性肿瘤(特别是惰性/滤泡性B细胞非霍奇金淋巴瘤[NHL]、CLL和华氏巨球蛋白血症[WM])患者中的最大耐受剂量(MTD)/Ib期以及后续试验的推荐剂量。 主要目的(Ib期 - 剂量扩展): 根据ORR(由研究者判定)评估PSB202的抗肿瘤活性。
次要目的(Ia期 - 剂量递增):确定PSB202的安全性特征和耐受性。确定PSB202的药代动力学(PK)和药效学(PD)特性。根据研究者评估的总反应率(ORR)评价PSB202的初步抗肿瘤活性。
次要目的(Ib期 - 剂量扩展):初步评估PSB202的抗肿瘤活性; 确定PSB202的安全性特征和耐受性。 确定PSB202的PK/PD特征以形成其生物学影响的证据
探索性目标(Ia期):确定PK和药物效应(包括疗效和安全性)之间的关系。
探索性目标(Ia期和Ib期):在达到临床应答CR的患者中,通过分子检测评价外周血和/或骨髓中的微小残留病变(MRD);在FL患者中:确定外周血BCL-2重排的逆转特性。
[Translation] Primary Objectives (Phase Ia - Dose Escalation): To determine the maximum tolerated dose (MTD)/recommended dose for Phase Ib and subsequent trials of PSB202 in patients with previously treated B-cell malignancies (specifically indolent/follicular B-cell non-Hodgkin lymphoma [NHL], CLL, and Waldenstrom's macroglobulinemia [WM]). Primary Objectives (Phase Ib - Dose Expansion): To evaluate the anti-tumor activity of PSB202 based on ORR (as assessed by investigator).
Secondary Objectives (Phase Ia - Dose Escalation): To determine the safety profile and tolerability of PSB202. To determine the pharmacokinetic (PK) and pharmacodynamic (PD) properties of PSB202. To evaluate the preliminary anti-tumor activity of PSB202 based on the investigator-assessed overall response rate (ORR).
Secondary Objectives (Phase Ib - Dose Expansion): To preliminarily evaluate the anti-tumor activity of PSB202; To determine the safety profile and tolerability of PSB202. Determine the PK/PD characteristics of PSB202 to form evidence of its biological impact
Exploratory objectives (Phase Ia): Determine the relationship between PK and drug effects (including efficacy and safety).
Exploratory objectives (Phase Ia and Phase Ib): In patients who achieve a clinical response (CR), evaluate minimal residual disease (MRD) in peripheral blood and/or bone marrow by molecular testing; in patients with FL: determine the reversal characteristics of BCL-2 rearrangements in peripheral blood.
A Phase 1a/1b Study of PSB202 in Patients With Previously Treated-, Relapsed-, Indolent B-Cell Malignancies
Product: PSB202 is a novel biological entity consisting of two engineered monoclonal antibodies, an Fc-enhanced humanized type II anti-CD20 IgG1 (PSB102) and a humanized anti-CD37 IgG1 (PSB107), that target B-cells. PSB202 is manufactured to work as a single product with the two components of PSB202 enabling a distinct dual target-specific antibody directed cell killing of B-cells.
Study: Multi-center-, International Phase 1a/1b (Escalation/Expansion) study in patients with indolent-, relapsed-, B-cell malignancies. The Phase 1a (Dose Escalation) part of study follows a 3+3 design.
100 Clinical Results associated with QLP-31907
100 Translational Medicine associated with QLP-31907
100 Patents (Medical) associated with QLP-31907
100 Deals associated with QLP-31907