NCT07083349尚未招募不适用
An Open, Single-Center Exploratory Clinical Study of NK510 Cell Therapy for Refractory Systemic Lupus Erythematosus
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 9
- 主要终点
- Response rate for SLE response index 4 (SRI4)
研究概览
简要总结
This is an investigator-initiated, open-label, single-arm study to determine safety and preliminary efficacy of NK510 for the treatment of patients with refractory systemic lupus erythematosus (SLE) in China.
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, male or female.
- •A diagnosis of SLE according to the 2019 EULAR (European League Against Rheumatism)/ACR (American College of Rheumatology).
- •The subject voluntarily participates in this clinical study and signs the Informed Consent Form (ICF).
- •Before screening, the subject must have received glucocorticoid combined with immunosuppressants and/or biological agents for at least 2 months, with a stable dose for more than 2 weeks, but the disease remains active; within 7 days before lymphodepleting conditioning, the blood routine test must meet the following requirements: absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; hemoglobin (Hb) ≥ 80g/L; platelet count (PLT) ≥ 50×10⁹/L.
- •SLEDAI-2K score > 8 points at screening.
- •Antinuclear antibody (ANA) ≥ 1:80 at screening.
- •Having appropriate organ functions:
- •Liver function: aspartate transaminase (AST) ≤ 3 times the upper limit of normal (ULN); alanine transaminase (ALT) ≤ 3 times ULN; total bilirubin ≤ 1.5 times ULN, unless the subject has a record of Gilbert syndrome; subjects with Gilbert-Meulengracht syndrome with total bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN can be included;
- •Renal function: serum creatinine ≤ 1.5 times ULN, or creatinine clearance rate ≥ 60 mL/min;
- •Blood routine: absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; absolute lymphocyte count (ALC) ≥ 0.1×10⁹/L; hemoglobin (Hb) ≥ 80 g/L; platelet count (PLT) ≥ 50×10⁹/L.
- •Women of childbearing age must be non-lactating and have a negative serum pregnancy test within 1 week before administration. In addition, all subjects (whether male or female) must agree to use contraception during the period of NK510 treatment starting from enrollment and within 3 months after the end of treatment.
- •Able to comply with the study protocol and follow-up procedures.
排除标准
- •Patients with active lupus nephritis.
- •Those with allergies to the study drug or other medications used in the study protocol.
- •Those with any of the following conditions: ① Having received autologous/allogeneic hematopoietic stem cell transplantation within 3 months; ② Having received ultraviolet irradiation therapy within 6 weeks; ③ Having received biologic agent therapy (excluding other medications used in the study protocol) within 4 weeks or 3 half-lives (whichever is longer); ④ Having undergone major surgery or received live vaccines within 4 weeks; ⑤ Having received experimental treatment (except for definite placebo control groups) within 4 weeks.
- •Those with other active, known, or suspected autoimmune diseases.
- •Presence of uncontrolled active bacterial, viral, fungal, mycobacterial, or other infections requiring treatment with intravenous antibiotics, antiviral drugs, or antifungal drugs within 14 days before lymphodepleting conditioning; however, prophylactic use of these drugs (including intravenous administration) is allowed.
- •History of immunodeficiency, including positive HIV test results, or other acquired/congenital immunodeficiency diseases, or history of organ transplantation.
- •History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac rhythm or conduction abnormalities (e.g., ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, etc.); QTc interval > 480 ms on 12-lead electrocardiogram at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events within 6 months before administration; New York Heart Association (NYHA) cardiac function class ≥ II or left ventricular ejection fraction (LVEF) < 50%.
- •Failure to fully recover from major surgery or trauma within 2 weeks before administration.
- •History of malignant tumors.
- •Screening results of hepatitis B or C virological tests meeting any of the following:
- •HBsAg positive, and peripheral blood HBV-DNA titer ≥ 1×10³ copies/mL or upper limit of normal;
- •Anti-HCV positive.
- •Those deemed unsuitable for participation in the study by the investigator.
结局指标
主要结局
Response rate for SLE response index 4 (SRI4)
时间窗: 3 months, 6 months after the first administration of NK510
SRI4 response defined as a reduction of ≥4 points on SLEDAI-2000, no new domain A scores and no more than 1 new domain B score on BILAG 2004, and no deterioration in PGA (\<0.3 point increase).
Incidence of treatment-related adverse events
时间窗: 1 year
This is to measure safety and tolerability of NK510
Dose-limiting toxicity (DLT) rate
时间窗: 28 days after initial study treatment.
This is to measure the dose-limiting toxicity of NK510
次要结局
- Changes of autoantibody of SLE from baseline(Day 14, 3 months, 6 months after the first administration of NK510)
- Number of participants who achieved clinical remission of SLE(3 months, 6 months after the first administration of NK510)
- Number of subjects who achieved lupus low disease activity state (LLDAS)(3 months, 6 months after the first administration of NK510)
- Number of subjects who achieved lupus low disease activity state (LLDAS)(3 months, 6 months after the first administration of NK510)
- Number of participants who achieved clinical remission of SLE(3 months, 6 months after the first administration of NK510)
- The change of SLEDAI-2000(Systemic lupus erythematosus disease activity index 2000) scores(Day 28, 3 months, 6 months after the first administration of NK510)
- Changes of autoantibody of SLE from baseline(Day 14, 3 months, 6 months after the first administration of NK510)
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