A Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the LVIVO-TaVec400 in the Treatment of Relapsed/Refractory Autoimmune Diseases
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 4
研究概览
简要总结
This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec400 in the treatment of relapsed/refractory autoimmune diseases.
详细描述
This is a prospective, single-arm, open-label dose-escalation and dose-expansion study, designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of the LVIVO-TaVec400, an in vivo chimeric antigen receptor (CAR) -T cell therapy in subjects with relapsed/refractory autoimmune diseases. The subject who meets the defined eligibility criteria will follow the sequential stages: screening, treatment (LVIVO-TaVec400 infusion) and follow-up (Up to 15 years).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily participate in clinical studies.
- •Age 18-65 years.
- •Adequate organ function at screening.
- •Clinical laboratory values meet criteria at screening visit.
- •Patients meet the 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) OR 2012 Systemic lupus international collaborating clinics (SLICC) classification criteria for SLE at least 6 months before screening.
- •At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody should be positive.
- •Fulfill relapsed/refractory SLE conditions.
- •r/r IgG4-RD：
- •Patients meet the 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for IgG4-RD.
- •Fulfill relapsed/refractory IgG4-RD conditions.
- •Patients have active disease: IgG4-RD Response Index (RI) ≥
- •Progressive MS：
- •Diagnosis of MS according to 2017 revised McDonald criteria.
- •Progressive MS according to clinical course criteria revised in
- •Presence of Cerebrospinal fluid (CSF) oligoclonal bands (OCBs) or elevated IgG Index at screening.
- •Diagnosis of MG.
- •Myasthenia Gravis Foundation of America (MGFA) Class II-IV.
- •Positive AChR-IgG or MuSK-IgG at screening.
- •Fulfill refractory MG conditions.
排除标准
- •Active infections such as hepatitis and tuberculosis.
- •Coexist other autoimmune or inflammatory diseases.
- •Severe underlying diseases such as tumor, uncontrolled diabetes and severe heart diseases.
- •Female subjects who are pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving LVIVO-TaVec400 treatment.
研究者
Qiubai Li
Director, Head of Department of Rheumatology and Immunology, Principal Investigator, Professor, Wuhan Union Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology