An Open-label Phase 2a Study to Evaluate the Safety and Efficacy of AlloNK®, an Allogeneic Cord Blood-derived NK Cell Therapy, in Combination With Rituximab in Relapsing Forms of B-cell Dependent Rheumatologic Diseases
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 77
- 主要终点
- Safety
研究概览
简要总结
A Basket Trial of Refractory Rheumatoid Arthritis (RA), Sjögren's Disease (SjD), Idiopathic Inflammatory Myopathies (IIMs) and Systemic Sclerosis (SSc) subjects to evaluate the safety and efficacy of AlloNK, a non-genetically modified allogeneic NK cell, in combination with rituximab.
详细描述
An open-label Phase 2a study to evaluate the safety and efficacy of AlloNK®, an allogeneic cord blood-derived NK cell therapy, in combination with rituximab in relapsing forms of B-cell dependent rheumatologic diseases.
AlloNK® (also known as AB-101) is a non-genetically modified, allogeneic, off-the-shelf, cryopreserved cord blood-derived NK cell 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Subjects with Refractory Rheumatoid Arthritis (RA):
- •Documented diagnosis of RA, meeting the 2010 ACR/EULAR classification criteria.
- •Rheumatoid Factor (RF) or Anti Citrullinated Protein Antibody (ACPA) positive.
- •High-sensitivity C-reactive protein (hs-CRP) > 3 mg/L or Erythrocyte Sedimentation Rate (ESR) > 28 mm/hr.
- •Have had prior treatment for a period of at least 12 weeks with a biologic disease modifying anti-rheumatic drug and were deemed refractory by the treating physician.
- •Minimum of six swollen joint counts (SJC) and six tender joint counts (TJC) according to joint assessment.
- •For subjects with Sjögren's Disease (SjD)
- •Prior diagnosis of Primary SjD as per 2016 ACR/EULAR criteria with confirmatory diagnosis in the 24 weeks preceding screening.
- •Total Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) >
- •Salivary Flow Rate > 0.1 mL/min on stimulation.
- •For subjects with Idiopathic Inflammatory Myopathies (IIMs)
- •Presence of a positive autoantibody (ANA >1:80 or RNP or SSA/SSB or other myositis specific autoantibodies.
- •Refractory IIM as defined by inadequate response/intolerance to at least 3 months of glucocorticoids and/or at least one other immunosuppressive.
- •Muscle biopsy or muscle MRI to confirm IIM diagnosis, where applicable, within 12 months prior to enrollment.
- •For Subjects with Systemic Sclerosis (SSc)
- •Diagnosis of SSc in accordance with the ACR/EULAR 2013 classification.
- •Modified Rodnan skin score (mRSS) >
- •Initial confirmatory diagnosis within 8 years of screening.
- •Refractory SSc as defined by inadequate response/intolerance to at least 3 months of glucocorticoids and/or at least one other immunosuppressive.
排除标准
- 未提供
研究组 & 干预措施
AlloNK
AlloNK, dosed after a conditioning regimen, combined with Rituximab.
干预措施: Allogeneic NK Cells (Drug)
结局指标
主要结局
Safety
时间窗: From enrollment until the end of treatment at Week 104.
Dose Limiting toxicities assessed in a incrementing dose design.
次要结局
- Rheumatoid Arthritis: Disease Activity Score 28 (DAS28 - ESR)(Week 52)
- Sjögren's Disease: Improvement in Clinical EULAR Sjögren's Syndrome Disease Activity Index (ClinESSDAI)(Week 52)
- Idiopathic Inflammatory Myopathies: Total Improvement Score (TIS)(Week 52)
- Systemic Sclerosis: Revised Composite Response Index in Systemic Sclerosis (rCRISS)(Week 52)