NCT06561009尚未招募1 期
Safety and Efficacy of BAFFR CART for Relapsed/ Refractory Neuromyelitis Optica Spectrum Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Incidence of dose-limiting toxicity (DLT)
研究概览
简要总结
This is an open-label, single-arm, dose-escalation study in up to 20 participants with relapsed/refractory Neuromyelitis Optica Spectrum Disorders (NMOSD). The aim is to evaluate the safety and efficacy of the treatment with BAFFR CART.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged 18-60 years;
- •Patients must be diagnosed as AQP4-IgG-positive NMOSD;
- •At least one immunosuppressant has been used for over a year with poorly controlled symptoms;
- •Clinical evidence of at least two relapses in the last 12 months or three relapses in the last 24 months and one relapse in the preceding 12 months before screening.
- •Subjects and their partners must be willing to use effective and reliable methods of contraception, devices or medicines, within one year before BAFFR CART cells infusion.
- •Subjects must provide written informed consent before the study begins and comply with the requirements of the study protocol.
排除标准
- •Subjects have received B cell deletion treatment within 6 months before screening;
- •Chronic and active hepatitis B (HBV), hepatitis C (HCV), Human Immunodeficiency Virus (HIV) infection, CMV or syphilis infections concurrently.
- •Subjects with Papovaviruses infection.
- •Subjects have received live attenuated vaccine vaccination within 8 weeks before screening; or plan to receive live vaccine vaccination within 8 weeks after treatment;
- •History of psychoactive drug abuse and failed to withdraw, or have a history of psychiatric disorders.
- •Pregnant or lactating women.
- •Subjects with severe heart, liver, kidney or bone marrow function disorder.
- •Allergic constitution or a history of severe allergies.
- •Subjects with conditions adjudicated by the investigator as unsuitable for lymphodepletion or cell infusion.
研究组 & 干预措施
Participant Group
Experimental
BAFFR CART cells
干预措施: Anti-BAFFR CART (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicity (DLT)
时间窗: Up to 28 days
Incidence of dose-limiting toxicity (DLT) will be evaluated within the first 28 days following BAFFR CART cells infusion.
Incidence and severity of adverse events
时间窗: Up to 28 days
Adverse events will be evaluated following the chemotherapy preparative regimen and infusion of BAFFR CART cells within the first 28 days.
次要结局
- Changes of visual acuity(Up to 1 years)
- Accumulated total active MRI lesions(Up to 1 years)
- Proportion of BAFFR CART cells in peripheral blood(Up to 1 years)
- Annualized relapse rate (ARR)(Up to 1 years)
- Changes of B cell levels in bone marrow and peripheral blood(Up to 1 years)
- Changes of AQP4 antibody titers(Up to 1 years)
- Changes of cytokine in peripheral blood(Up to 1 years)
- Changes of Expanded Disability Status Scale (EDSS) score(Up to 1 years)
研究者
Qiang Liu
Department of Neurology
Tianjin Medical University General Hospital
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