NCT06752876撤回1 期
A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients With Refractory Systemic Lupus Erythematosus (GALLOP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 20
- 主要终点
- Incidence of critical safety events (CSEs) ≤ 28days after CB-010 infusion
研究概览
简要总结
This is a Phase 1 study to evaluate the safety and efficacy of a single infusion of CB-010 in patients with refractory Systemic Lupus Erythematosus (SLE) with cohorts for lupus nephritis (LN) and extrarenal lupus (ERL).
详细描述
Participants enrolled can expect to be on the study for a total duration of approximately 2 years, during which there will be a screening period followed by a single administration of CB-010 and then 24 months of safety follow-up and monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Clinical diagnosis of SLE according to 2019 EULAR/ACR classification criteria for at least 6 months
- •Cohort 1 LN:
- •Class III or IV lupus nephritis
- •Urine protein-to-creatinine ratio (UPCR) ≥ 0.8 mg/mg
- •Refractory to glucocorticoids and at least 2 immunosuppressive therapies
- •Cohort 2 ERL (Patients with class I and II LN may be included in the ERL cohort if their SLEDAI-2K is ≥ 8):
- •SLEDAI-2K ≥ 8
- •Refractory to glucocorticoids, and at least 2 immunosuppressive therapies
- •Adequate renal, hepatic, pulmonary, and cardiac function, with specific laboratory criteria
- •Females must be either of nonchildbearing potential, defined as postmenopausal or surgically sterile or agree to use a highly effective double barrier method of contraception or vasectomized partner
排除标准
- •Has active severe central nervous system (CNS) lupus in the previous 3 months from planned LD start date
- •Has received any other investigational treatment for any indication within the 4 weeks or 5 half-lives
- •Prior treatment with cellular therapy (genetically modified cells), gene therapy directed at any target, allogenic or autologous stem cell transplant or organ transplant
- •History of infection with human immunodeficiency virus or evidence of hepatitis B or C virus infection
- •History of hypersensitivity to Cyclophosphamide, Fludarabine, or any of the components of CB-010
- •Received a live vaccine ≤ 6 weeks prior to start of LD
- •Patients for whom magnetic resonance imaging (MRI) studies are contraindicated or who cannot tolerate them
研究组 & 干预措施
Cohort 1 Lupus Nephritis (LN)
Experimental
干预措施: CB-010 (Drug)
Cohort 2 Extrarenal Lupus (ERL)
Experimental
干预措施: CB-010 (Drug)
结局指标
主要结局
Incidence of critical safety events (CSEs) ≤ 28days after CB-010 infusion
时间窗: Through 28 days
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)
时间窗: Through end of study (approximately 2 years)
次要结局
- To characterize the PK profile of a single infusion of CB-010 (i.e., CB-010 expansion and persistence)(Through end of study (approximately 2 years))
研究者
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