NCT06249438招募中1 期
An Exploratory Clinical Study of Cluster of Differentiation Antigen 20(CD20)/Anti-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
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events [Safety and Tolerability]
研究概览
简要总结
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
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 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 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.
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.
- •≥ 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.
研究组 & 干预措施
C-CAR168
Experimental
Autologous C-CAR168 administered by intravenous (IV) infusion
干预措施: CD20/BCMA-directed CAR-T cells (Biological)
结局指标
主要结局
Incidence of Adverse Events [Safety and Tolerability]
时间窗: Throughout the first 24 months follow up period completion (3 years)，DLTs will be observed/collected throughout the 28 days post C-CAR168 infusion
Incidence of any adverse events (AEs), including dose limiting toxicities (DLTs)
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 (3 years)
Based on the assessment of dose-limiting toxicities (DLTs) rates and overall safety profile
次要结局
- The proportion of subjects who achieved glucocorticoids/immunosuppressant free and subjects who achieved low-dose glucocorticoids application during the main study period(Throughout the first 24 months follow up period completion (3 years))
- The clearance of peripheral blood B cell(Throughout the first 24 months follow up period completion (3 years))
- Time to response (TTR)(Throughout the first 24 months follow up period completion (3 years))
- Time to reach the maximal plasma concentration (Tmax)(Throughout the first 24 months follow up period completion (3 years))
- The elevation of peripheral blood complement(Throughout the first 24 months follow up period completion (3 years))
- The decline of autoantibodies or other disease specific biomarkers(Throughout the first 24 months follow up period completion (3 years))
- The proportion of subjects who achieved remission during the main study period(Throughout the first 24 months follow up period completion (3 years))
- The proportion of subjects who achieved remission at 6 months (6M)(Throughout the first 6 months follow up period completion (1.5 years))
- The proportion of subjects who experienced relapse during the main study period(Throughout the first 24 months follow up period completion (3 years))
- Progression-free survival (PFS)(Throughout the first 24 months follow up period completion (3 years))
- Maximal plasma concentration (Cmax)(Throughout the first 24 months follow up period completion (3 years))
- Duration in peripheral blood (Tlast)(Throughout the first 24 months follow up period completion (3 years))
- Area under curve (AUC)(Throughout the first 24 months follow up period completion (3 years))
- The decline of serum immunoglobulin(Throughout the first 24 months follow up period completion (3 years))
研究者
研究点 (1)
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相关资讯
AbelZeta's Novel Bispecific CAR-T Therapy Shows Promise for Refractory Autoimmune Diseases in First-in-Human Trial- AbelZeta Pharma will present clinical data from the first-in-human Phase I trial of C-CAR168, an anti-CD20/BCMA bispecific CAR-T therapy, at ACR Convergence 2025.
- The therapy is designed to simultaneously target autoantibody-producing plasma cells and their B-cell precursors to achieve "immune reset" in refractory autoimmune diseases.
- The abstract title indicates the therapy promotes immune reset and sustained drug-free remission in patients with treatment-resistant autoimmune conditions.
- This represents a novel application of CAR-T technology beyond oncology, potentially offering new hope for patients with difficult-to-treat autoimmune disorders.11 months agoAbelZeta's C-CAR168 Shows Promising Results in Treating Refractory Lupus Nephritis and Multiple Sclerosis- Novel bispecific CAR-T therapy C-CAR168 targeting CD20/BCMA demonstrated positive safety profile with only low-grade cytokine release syndrome in early clinical trials for autoimmune diseases.
- Among four lupus nephritis patients reaching 6-month evaluation, all achieved SRI(4) response with two complete remissions, allowing discontinuation of immunosuppressants and steroids in most patients.
- Early efficacy signals were observed in a Secondary Progressive Multiple Sclerosis patient, including improved gait, reduced brain inflammation, and better functional assessment scores.last year