NCT07676266尚未招募1 期
An Exploratory Clinical Study of Anti-CD20/B-cell Maturation Antigen (BCMA) Chimeric Antigen Receptor Autologous T Cell Product (C-CAR168) in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Incidence and severity of Adverse Events [Safety and Tolerability]
研究概览
简要总结
This is an investigator-initiated, single-center, 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 70 years old at the time of signing the Informed Consent Form (ICF).
- •Diagnosed as Multiple sclerosis (MS)/Neuromyelitis Optica Spectrum Disorders (NMOSD)/Myasthenia Gravis (MG)/Systemic Lupus Erythematosus (SLE)/ Systemic Sclerosis (SSc)/ Immune-Mediated Necrotizing Myopathy (IMNM) according to recognized diagnostic criteria for at least 6 months.
- •Prior treatment failure with standard therapy.
- •Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function.
排除标准
- •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.
- •A history of ≥ Grade 2 bleeding within 4 weeks 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.
- •Any contraindication to lumbar puncture for MS or NMOSD.
结局指标
主要结局
Incidence and severity of Adverse Events [Safety and Tolerability]
时间窗: Throughout the first 3 months follow up period completion
Incidence and severity of adverse events (AE) and serious adverse events (SAE) within three months following infusion
The subsequent recommended dose of C-CAR168 in patients with autoimmune diseases refractory to standard therapy
时间窗: Throughout the first 24 months follow up period completion
Based on the assessment of overall safety profile
次要结局
- PD: Decline of serum immunoglobulin(Throughout the first 24 months follow up period completion)
- Incidence and severity of adverse events (AE)(Throughout the first 24 months follow up period completion)
- MS: No Evidence of Disease Activity-3 (NEDA-3)(Throughout the first 24 months follow up period completion)
- MS and NMOSD: Expanded Disability Status Scale (EDSS)(Throughout the first 24 months follow up period completion)
- MS and NMOSD: MRI(Throughout the first 24 months follow up period completion)
- MS and NMOSD: Annualized Relapse Rate (ARR)(Throughout the first 24 months follow up period completion)
- MG: Minimal Symptom Expression (MSE) and Minimal Clinically Important Difference (MCID)(Throughout the first 24 months follow up period completion)
- MG: Quantitative Myasthenia Gravis Score (QMGS)(Throughout the first 24 months follow up period completion)
- MG: Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale(Throughout the first 24 months follow up period completion)
- SLE: Definition Of Remission In SLE (DORIS), Lupus Low Disease Activity State (LLDAS), Systemic Lupus Erythematosus Responder Index-4 (SRI-4)(Throughout the first 24 months follow up period completion)
- SLE: Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K),(Throughout the first 24 months follow up period completion)
- IMNM: Definition Of Improvement (DOI)(Throughout the first 24 months follow up period completion)
- IMNM: Manual Muscle Test (MMT)(Throughout the first 24 months follow up period completion)
- SSc: Revised Composite Response Index in Systemic Sclerosis (r-CRISS)(Throughout the first 24 months follow up period completion)
- SSc: modified Rodnan Skin Score (mRSS), FVC%(Throughout the first 24 months follow up period completion)
- PK：Maximal plasma concentration (Cmax)(Throughout the first 24 months follow up period completion)
- PK: Time to reach the maximal plasma concentration (Tmax)(Throughout the first 24 months follow up period completion)
- PK: Duration in peripheral blood (Tlast)(Throughout the first 24 months follow up period completion)
- PK: Area under curve (AUC)(Throughout the first 24 months follow up period completion)
- PD: Depletion of peripheral blood B cells, plasma cells, and CD20dim T cells(Throughout the first 24 months follow up period completion)
研究者
研究点 (1)
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