肿瘤细胞治疗研究
英文原题：A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
⚠ 该试验的登记信息已有 14 个月未更新， 页面上显示的「招募中」可能已经失效。联系研究中心之前，建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。
这是一项 I 期注册临床试验，评估 BCMACAR-T 细胞治疗系统性红斑狼疮、多发性骨髓瘤、视神经脊髓炎的安全性、可行性及初步疗效。当前状态：招募中。计划入组 30 例。试验地点：中国 · 上海（共 1 个中心，其中中国 1 个）。登记号：NCT06249438。
不限性别 · ≥ 18 Years 且 ≤ 70 Years
纳入标准： • 签署知情同意书时年龄18至70岁。 • 根据公认诊断标准确诊系统性红斑狼疮（SLE）、免疫介导坏死性肌病（IMNM）、视神经脊髓炎谱系障碍（NMOSD）、多发性硬化（MS）、重症肌无力（MG）或系统性硬化症（SSc）至少6个月。 • 接受标准治疗至少8周后疾病仍活动或复发，且剂量稳定超过2周；患者须至少接受过两种免疫抑制治疗（包括免疫抑制剂、生物制剂和疾病修饰药物〔DMD〕）。 • 骨髓、凝血、心肺、肝及肾功能足够。 排除标准： • 乙型肝炎病毒（HBV）、丙型肝炎病毒（HCV）、人类免疫缺陷病毒（HIV）、梅毒螺旋体（TP）阳性；巨细胞病毒（CMV）DNA阳性；EB病毒（EBV）DNA阳性。 • 未控制的活动性感染。 • 签署知情同意书前4周内接种活疫苗。 • 有主要器官移植或骨髓/造血干细胞移植史。 • 筛查前6个月内患严重心血管疾病。 • 筛查前30天内出现≥2级出血，或需长期抗凝治疗。 • 既往治疗洗脱期不足。 • 既往接受过CAR-T细胞产品或基因修饰T细胞疗法。 • 妊娠或哺乳期女性。 • 存在严重中枢神经系统疾病或病变。 • 签署知情同意书前5年内有恶性肿瘤史。
Inclusion Criteria: * 18 to 70 years old at the time of signing the Informed Consent Form (ICF). * Diagnosed as SLE/Immune-Mediated Necrotizing Myopathy (IMNM)/Neuromyelitis Optica Spectrum Disorders (NMOSD)/Multiple Sclerosis (MS)/Myasthenia Gravis (MG)/Systemic Sclerosis (SSc) according to recognized diagnostic criteria for at least 6 months. * Remains disease active or relapses after treatment with standard of care therapy for at least 8 weeks with the dose stable for more than 2 weeks; patients should have been treated with at least two immunosuppressants (including immunosuppressants, biologics, and disease-modifying drug (DMD) ). * Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function. Exclusion Criteria: * Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive, Epstein-Barr Virus (EBV) DNA positive. * Uncontrolled active infection. * Live vaccine injection within 4 weeks prior to signing the ICF. * Major organ transplantation history or bone marrow/hematopoietic stem cell transplantation history. * Severe cardiovascular diseases within the past 6 months prior to screening. * ≥ Grade 2 bleeding within the past 30 days prior to screening, or requiring long-term anticoagulants treatment. * Inadequate washing time for previous treatment. * Previously treated with CAR-T cell products or genetically modified T cell therapies. * Pregnant or lactating women. * Severe central nervous system diseases or pathological changes. * Malignancy history within 5 years prior to signing the ICF.
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：Incidence of Adverse Events [Safety and Tolerability] · Incidence of any adverse events (AEs), including dose limiting toxicities (DLTs) · Throughout the first 24 months follow up period completion (3 years)，DLTs will be observed/collected throughout the 28 days post C-CAR168 infusion；The subsequent recommended dose of C-CAR168 in patients with autoimmune diseases refractory to standard therapy · Based on the assessment of dose-limiting toxicities (DLTs) rates and overall safety profile · Throughout the first 24 months follow up period completion (3 years)
次要终点：The proportion of subjects who achieved remission at 6 months (6M)；The proportion of subjects who achieved remission during the main study period；The proportion of subjects who experienced relapse during the main study period；Time to response (TTR)；Progression-free survival (PFS)；The proportion of subjects who achieved glucocorticoids/immunosuppressant free and subjects who achieved low-dose glucocorticoids application during the main study period；Maximal plasma concentration (Cmax)；Time to reach the maximal plasma concentration (Tmax)
通过静脉输注给予自体C-CAR168。
这是一项研究者发起、多中心、开放标签研究，评估自体双特异性CAR-T疗法C-CAR168（靶向CD20和BCMA）治疗标准治疗难治的成人自身免疫性疾病患者。
This is an investigator-initiated, multicenter, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard therapy
MEMBER ACCOUNT
登录成功会直接打开下一页。
