NCT06485232尚未招募早期 1 期
An Exploratory Study on the Safety and Efficacy of Universal CAR-T Cells Targeting BCMA and CD19 in the Treatment of Refractory Autoimmune Diseases of the Nervous System
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Incidence of dose-limiting toxicities(DLTs)
研究概览
简要总结
This is an open label, single-site, dose-escalation study in up to 25 participants with refractory autoimmune diseases of nervous system. This study aims to evaluate the safety and efficacy of the treatment with universal BCMA and CD19 CART.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years (for MS patients, 18-55 years); both genders eligible.
- •Subjects with refractory neurological autoimmune diseases who have failed standard treatment or lack effective treatment, Including neuromyelitis optica spectrum disorders(NMOSD), generalized myasthenia gravis(gMG), chronic inflammatory demyelinating Polyradiculoneuropathy(CIDP) and multiple sclerosis(MS).
- •Anticipated survival of ≥ 12 weeks as judged by the researcher.
- •Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication.
- •Provides written informed consent.
排除标准
- •History of solid organ transplantation.
- •Malignant tumor within the last two years.
- •Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.
- •Primary immunodeficiency (congenital or acquired).
- •Severe cardiac disease.
- •History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal.
- •Allergic constitution or a history of severe allergies.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
BCMA CAR-T Group
Experimental
Universal BCMA CAR-T
干预措施: Universal BCMA CAR-T (Drug)
CD19 CAR-T Group
Experimental
Universal CD19 CAR-T
干预措施: Universal CD19 CAR-T (Drug)
BCMA CAR-T + CD19 CAR-T Group
Experimental
Universal BCMA CAR-T; Universal CD19 CAR-T
干预措施: Universal BCMA CAR-T; Universal CD19 CAR-T (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicities(DLTs)
时间窗: First 28 days after infusion
Incidence of dose-limiting toxicities(DLTs)
Incidence of adverse events(AEs) and severe adverse
时间窗: Up to 12 months after infusion
Incidence of adverse events(AEs) and severe adverse events(SAEs).
次要结局
- B cell levels in peripheral blood(3 months)
- MS: Changes of the number of Gd-enhancing T1 Lesions(6, 12months)
- MS: Changes of the number of Number of New or Enlarging T2 Lesions(6, 12months)
- Concentrations of UCAR-T cells(3 months)
- Changes of pathogenic antibody titers after infusion(1, 3, 6 ,12months)
- NMOSD: Annualized relapse rate(6, 12months)
- gMG: Changes of Myasthenia Gravis Activities if Daily Living (MG-ADL) Score(1, 3, 6, 12months)
- CIDP:Changes of Inflammatory Neuropathy Cause and Treatment (INCAT) Score after infusion.(1, 3, 6, 12months)
研究者
研究点 (1)
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