驯鹿生物全人源BCMA CAR-T细胞伊基仑赛注射液新增自身免疫性疾病适应症IND申请获受理

2022-06-02 网络 网络

驯鹿生物宣布国家药品监督管理局(NMPA)已正式受理全人源BCMA嵌合抗原受体自体T细胞注射液(伊基仑赛注射液,福可苏®,研发代号CT103A)新增扩展适应症抗体介导的视神经脊髓炎谱系疾病(N

驯鹿生物宣布国家药品监督管理局(NMPA)已正式受理全人源BCMA嵌合抗原受体自体T细胞注射液(伊基仑赛注射液,福可苏®,研发代号CT103A)新增扩展适应症抗体介导的视神经脊髓炎谱系疾病(Neuromyelitis Optica Spectrum Disorder,NMOSD)的临床试验申请(IND),这是全球第一个CAR-T在NMOSD疾病领域的IND申请。

此次新适应症申请是基于伊基仑赛注射液研究者发起的临床研究(Investigator Initiated Trial,IIT),研究入组的受试者为至少使用一种免疫抑制剂治疗一年以上,但症状控制欠佳的难治性视神经脊髓炎谱系疾病患者。本研究的主要目的是观察伊基仑赛注射液治疗NMOSD受试者的安全性、耐受性,以及初步的疗效、药代动力学(Pharmacokinetics,PK)、药物动力学(Pharmacodynamics,PD)相关指标。截至2022年3月20日,12例受试者接受了伊基仑赛注射液回输,其中0.5×106 CAR-T细胞/kg剂量组3例受试者、爬坡阶段与扩展阶段1.0×106 CAR-T细胞/kg剂量组分别3例和6例受试者接受了伊基仑赛注射液CAR-T细胞回输。

研究数据初步显示了0.5×106 CAR-T细胞/kg与1.0×106 CAR-T细胞/kg剂量组伊基仑赛注射液在治疗传统疗法控制不佳的NMOSD受试者时展示了较为可靠的安全性,所有的CRS(Cytokine Release Syndrome,细胞因子释放综合征)均为1-2级,未观察到任何ICANS(Immune Effector Cell Associated Neurologic Syndrome, 免疫效应细胞相关神经系统综合征)。有效性方面,50%受试者视力改善,67%受试者行走能力改善,75%受试者直肠膀胱功能改善。

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    2023-01-01 仁者大医
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    2022-06-04 yykkxiaodou
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    2022-06-04 xiaogang319
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