Xingang Biomedical Technology (Shanghai) Co., Ltd.

By conducting single and multiple dose escalation studies of NBT508 monotherapy in patients with R/R B-NHL, the safety and tolerability of intravenous injection of humanized anti-CD79b monoclonal antibody-MMAE conjugate for injection was observed, the maximum tolerated dose and pharmacokinetic characteristics were determined, and a reference basis for Phase Ib/II clinical studies was provided, and the immunogenicity and preliminary efficacy of NBT508 were preliminarily evaluated. Main purpose: Evaluate the safety and tolerability of humanized anti-CD79b monoclonal antibody-MMAE conjugate for injection (NBT508 for injection) in patients with R/R B-NHL, determine the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD), and provide a basis for the selection of the recommended dose (RP2D) for Phase Ib/II trials. Secondary purpose: ? Evaluate the pharmacokinetic (PK) characteristics of NBT508 for injection in patients with R/R B-NHL; ? Evaluate the immunogenicity of NBT508 for injection in patients with R/R B-NHL; ? To evaluate the preliminary efficacy of NBT508 for injection in the treatment of R/R B-NHL. Exploratory purpose: ? If data permit, characterize the PK characteristics of NBT508 for injection in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma based on population pharmacokinetic (PopPK) analysis. ? If data permit, evaluate the relationship between the in vivo exposure of NBT508 for injection and efficacy and adverse events.