An Open Label, Single Arm Study to Assess Safety, Efficacy and Persistence of ACE1831, in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of ACE1831 in subjects with Refractory Systemic lupus erythematosus
研究概览
简要总结
ACE1831 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment in subjects with Relapsed/Refractory Systemic lupus erythematosus (SLE)
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 to 60 years (inclusive)
- •History of meeting the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria, or the 1997 ACR criteria, or the 2012 Systemic Lupus International Collaborating Clinics (SLICC)
- •Presence of anti-dsDNA antibodies and/or anti-nuclear antibodies (ANA) and/or anti-Smith (anti-Sm) antibodies positive
- •SLE is in the moderate to severe active phase with the SLEDAI-2000 score ≥ 8
- •At least one British Isle Lupus Rating Group Index (BILAG-2004) Class A (severe manifestation) or two Class B (moderate manifestation) organ scores, or both
- •Inadequate response to glucocorticoids and at least 2 of treatments used for at least 3 months
- •Women of childbearing potential and their partners must agree to use at least 1 highly effective method of contraception throughout the study period and for 1 year after treatment
- •Signed informed consent
排除标准
- •Severe lupus nephritis requiring prohibited medications for active nephritis treatment，or hemodialysis, or eGFR < 50 ml/min/1.73m²
- •Central nervous system disease caused by SLE or other conditions
- •Significant medical history that would pose a risk to the patients safety from the investigator's opinion, or patients medical condition could worsen during the study
- •Malignancies within 5 years
- •Presence of active, recurrent, chronic infection requiring treatment , or latent infection (HBV, HCV, HIV, TB, syphilis)
- •Received any B-cell depletion biologic therapy
- •Received immunosuppressive small molecule drug therapy， or other systemic corticosteroid therapy ， or prednisone
- •Pregnant or lactating women
研究组 & 干预措施
Participant
The single, open label study arm includes 2 dose escalation cohorts:
Cohort 1: Receives ACE1831 (Dose Level 1) with LDC depending on assignment Cohort 2: Receives ACE1831 (Dose Level 2) with LDC depending on assignment
干预措施: ACE1831 (Drug)
Participant
The single, open label study arm includes 2 dose escalation cohorts:
Cohort 1: Receives ACE1831 (Dose Level 1) with LDC depending on assignment Cohort 2: Receives ACE1831 (Dose Level 2) with LDC depending on assignment
干预措施: Lymphodepleting chemotherapy (Drug)
结局指标
主要结局
To assess the safety and tolerability of ACE1831 in subjects with Refractory Systemic lupus erythematosus
时间窗: 24 weeks after last dose of ACE1831
To assess the incidence of Adverse Events (AEs), \[AEs including Treatment Emergent AEs, Serious AEs (SAEs), AEs of Special Interests (AESIs), and dose limiting toxicities (DLTs)\] (unit: number of AEs)
次要结局
- To assess the efficacy of ACE1831 ：Changes in SF-12 score(24 weeks after last dose of ACE1831)
- To assess the efficacy of ACE1831: LLDAS rate(24 weeks after last dose of ACE1831)
- To assess the efficacy of ACE1831： Changes in SLE disease activity Index (SLEDAI-2000) score(24 weeks after last dose of ACE1831)
- To assess the efficacy of ACE1831 (secondary efficacy)：Changes in PGA(24 weeks after last dose of ACE1831)
- To assess the efficacy of ACE1831 ：Changes in BILAG-2004 score(24 weeks after last dose of ACE1831)
- To assess the efficacy of ACE1831 : Changes in SGA(Time Frame: 24 weeks after last dose of ACE1831)
- To assess the efficacy of ACE1831 ：Changes in LupusQOL(24 weeks after last dose of ACE1831)
- To assess the efficacy of ACE1831 ：Changes in EQ-5D-5L score(24 weeks after last dose of ACE1831)
- To assess the efficacy of ACE1831: SRI-4 response rate(24 weeks after last dose of ACE1831)
- To assess the efficacy of ACE1831: DORIS(24 weeks after last dose of ACE1831)
- Persistence of ACE1831 after administration(8 weeks after last dose of ACE1831)
- Measure the pharmacodynamics change of ACE1831(24 weeks after last dose of ACE1831)
- Immunogenicity(24 weeks after last dose of ACE1831)
研究者
Lingli Dong
Director of the department of rheumatology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Tongji Hospital