NCT06994143招募中1 期
A Phase I, Open-Label Study of CLN-978 in Patients With Treatment-Refractory Rheumatoid Arthritis (RA)
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
- 37
- 试验地点
- 4
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
A Phase I, open-label study of CLN-978 in patients with treatment-refractory rheumatoid arthritis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of RA which fulfills the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria ≥12 weeks prior to screening.
- •Evidence of B-cell-driven disease at Screening or previous medical documentation, defined as either (i) seropositivity for RF and/or any AMPA and/or (ii) a synovial biopsy showing B-cell infiltration
- •Active RA disease, as demonstrated by a DAS28 - ESR ≥3.2 and at least one swollen joint at screening.
- •Inadequate response to at least 2 targeted treatments with different mechanisms. These can include tsDMARD and/or bDMARD, after failing conventional synthetic DMARD (unless contraindicated).
- •Local laboratory assessments must meet the following criteria:
- •Absolute lymphocyte count (ALC) ≥0.5 x 10^9/L
- •Peripheral CD19+ B cell count ≥25 cells/μL
- •Absolute neutrophil count (ANC) ≥1.0 x 10^9/L
- •Hemoglobin (Hgb) ≥8 g/dL
- •Platelet count ≥75 x 10^9/L
- •Estimated glomerular filtration rate (eGFR) (based on the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) ≥30 mL/min/1.73m^2
- •Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN
- •Concurrent corticosteroids is permitted if the dose is ≤10 mg/day prednisone equivalent in the 2 weeks prior to initiation of study treatment. Hydroxychloroquine ≤400 mg/d or chloroquine ≤ 250 mg/d is allowed.
排除标准
- •Active inflammatory disease other than RA within 12 months prior to screening or during screening that may interfere with the study assessments. Thyroiditis or secondary Sjogren's syndrome is allowed.
- •Clinical evidence of any other significant unstable or uncontrolled acute or chronic disease not due to RA which, in the opinion of the Investigator could put the patient at undue risk or confound study results.
- •Prior treatment with the following:
- •Cellular therapy (e.g., chimeric antigen receptor T-cell (CAR-T) or gene therapy product directed at any target.
- •Receipt of an investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1 and during the study.
- •Received any anti-CD19 or anti-CD20 therapy such as blinatumomab, obinutuzumab, rituximab, ocrelizumab, or ofatumumab within 3 months prior to Day
- •Non-biologic DMARD within 14 days prior to Day
- •Cyclophosphamide or a biologic immunomodulating therapy within 2 months of Day
- •Live or live-attenuated vaccines within the 4 weeks prior to the Screening visit or during the Screening Period
- •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.
研究组 & 干预措施
Part A: Dose Escalation
Experimental
Patients with RA treated with CLN-978 in dose escalation cohorts
干预措施: CLN-978 (Drug)
Part B Further Dose Evaluation
Experimental
Further evaluation of CLN-978 treatment of patients with RA
干预措施: CLN-978 (Drug)
结局指标
主要结局
Incidence and severity of adverse events
时间窗: 48 wks
Incidence and severity of adverse events (AEs)/adverse events of special interest (AESIs)/serious adverse events (SAEs)
次要结局
- Serum concentrations of CLN-978(12 wks)
- Level of anti-drug antibodies(12 wks)
- Pharmacodynamics-related biomarker(48 wks)
研究者
研究点 (4)
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