安全性评估显示，CM336安全性和耐受性良好。剂量成功递增至160 mg，且尚未达到最大耐受剂量。最常见的不良事件为细胞因子释放综合徵(CRS)、淋巴细胞计数降低和贫血。大多数CRS事件为1级事件，仅7%(5/68)受试者发生2级CRS事件，未发生免疫效应细胞相关神经毒性综合徵。Kangnuo Ya-B (02162) published an announcement regarding its BCMAxCD3 targeted bispecific antibody CM336 treatment...
According to the Zhito Finance APP, Kangnuo Ya-B (02162) has released an announcement that the latest data from the phase I/II clinical study of its BCMAxCD3 bispecific antibody CM336 for the treatment of relapsed or refractory multiple myeloma was presented in poster form at the 66th Annual Meeting of the usa Hematology (ASH).
The purpose of this phase I/II clinical study is to evaluate the safety, tolerance, and preliminary efficacy of CM336 in subjects with relapsed or refractory multiple myeloma. As of October 30, 2024, a total of 68 subjects have been enrolled in the study (25 in the dose escalation phase and 43 in the dose expansion phase). All subjects had previously received proteasome inhibitors, immunomodulators, and anti-CD38 monoclonal antibody therapy, with a median of 4 lines of prior treatment.
The safety assessment showed that CM336 has good safety and tolerance. The dose was successfully escalated to 160 mg, and the maximum tolerated dose has not yet been reached. The most common adverse events were cytokine release syndrome (CRS), decreased lymphocyte count, and anemia. Most CRS events were grade 1, with only 7% (5/68) of subjects experiencing grade 2 CRS events, and no immune effector cell-associated neurotoxicity syndrome occurred.
In the dose escalation phase, the median follow-up time was 12.1 months, with 52% (12/23) of subjects achieving stringent complete response (sCR) or complete response (CR). With a median follow-up of 3.1 months, the overall objective response rates (ORR) for the 3/20/80 mg and 3/20/80/160 mg dose groups (including both dose escalation and expansion phases) were 67% (16/24) and 76% (19/25), respectively, with some patients yet to reach the best efficacy response. Among 19 subjects with measurable minimal residual disease (MRD), the MRD negative rate was 95% (18/19), with a median time to reach MRD negativity of 2.1 months.
In this study, CM336 demonstrated good overall safety and tolerance. CM336 exhibited preliminary efficacy in subjects with relapsed or refractory multiple myeloma.