NCT06613360招募中1 期
A Phase 1b, Open-label, Pilot Study of CLN-978 for the Treatment of Moderate to Severe Systemic Lupus Erythematosus (SLE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 22
- 主要终点
- Safety and tolerability
研究概览
简要总结
Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Diagnosis of SLE at least 24 weeks prior to Screening and meet 2019 EULAR / ACR Classification Criteria at screening.
- •Presence of one or more of the following autoantibodies documented during screening or in the previous 12 months before screening: positive anti-nuclear antibody (ANA) test (≥1:80); anti dsDNA above the upper limit of normal (ULN); anti-Sm above the ULN.
- •Active SLE disease, as demonstrated by a SLEDAI total score ≥6 at screening.
- •Inadequate response to at least 2 of the following treatments: oral corticosteroid, antimalarials, conventional immunosuppressants, or biologics. At least one of the failed treatments should be an immunosuppressive or biologic standard-of care agent.
- •If on corticosteroid and/or antimalarial, the dose must be stable prior to day
- •Laboratory parameters including the following:
- •Absolute lymphocyte count (ALC) ≥0.5 x 109/L
- •Peripheral B cell count ≥25 cells/µL
- •Absolute neutrophil count (ANC) ≥1.0 x 109/L
- •Hemoglobin ≥8 g/dL
- •Platelet count ≥75 x 109/L.
- •Estimated glomerular filtration rate (eGFR) (based on CKD-EPI formula) ≥30 mL/min/1.73m2
- •Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN
- •Part B only: For patients who were treated in Part A and did not experience dose-limiting toxicity (DLT) or discontinue CLN-978 treatment due to AEs are eligible for retreatment at a higher dose or longer schedule in Part B if they otherwise meet eligibility criteria and at least 90 days have passed since the last dose of CLN-978.
排除标准
- •Active inflammatory disease other than SLE. Thyroiditis or secondary Sjogren's syndrome is allowed.
- •Considered at high risk for thrombosis.
- •Rapidly progressive glomerulonephritis, and/or urine protein/creatinine >3 mg/mg (339 mg/mmol).
- •Active severe neuropsychiatric/CNS manifestations of SLE.
- •Evidence of hepatitis B, hepatitis C (HCV) infection, human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection.
- •History of splenectomy.
- •Prior treatment with the following:
- •Cellular or gene therapy product directed at any target.
- •Investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day
- •Any anti-CD19 or anti-CD20 therapy less than 3 months prior to Day
- •Non-biologic DMARD within 14 days prior to Day
- •Cyclophosphamide within 1 month or a biologic immunomodulating therapy during 2 months prior to Day
- •Live or attenuated vaccine within 28 days prior to screening or during screening.
- •Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including SARS-CoV-2 infection, within 14 days before Day
- •Active or latent tuberculosis (TB) evidenced by a positive or indeterminant Interferon Gamma Release Assay (IGRA), unless the patient has documented previous completion of TB treatment and no current clinical indication of TB.
- •Any condition for which, in the opinion of the Investigator and/or Sponsor, would not be in the best interest of the patient to participate in the study or that could prevent, limit, or confound any protocol-defined assessment.
研究组 & 干预措施
Part B Further Dose Evaluation
Experimental
Further evaluation of CLN-978 treatment of patients with SLE
干预措施: CLN-978 (Drug)
Part A Dose Escalation
Experimental
Patients with SLE treated with CLN-978 in dose escalation cohorts
干预措施: CLN-978 (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 48 weeks
Incidence and severity of adverse events (AEs)/adverse events of special interest (AESIs)/serious adverse events (SAEs)
次要结局
- Pharmacodynamics-related biomarker(48 weeks)
- Pharmacokinetics(48 weeks)
- Immunogenicity(48 weeks)
研究者
研究点 (22)
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