NL-OMON55948尚未招募不适用
An Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Doses of ELA026 in Participants with Secondary Hemophagocytic Lymphohistiocytosis (sHLH). - An open-label study to evaluate safety and efficacy of ELA026.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •1. >=12 years at the time of sHLH diagnosis (Cohort 1)
- •2. >=6 years at the time of sHLH diagnosis (Cohorts 2-4)
- •Type of Participant and Disease Characteristics (Cohort 1-2)
- •1. Treatment naïve (participants >=12 years of age only), OR
- •2. Relapsed or refractory sHLH defined as:
- •a. Participant has failed to respond to 2 weeks of treatment with
- •tociluzumab, anakinra, or other HLH therapy with a less than 50%
- •decrease in serum ferritin, OR
- •b. Participant has received 4 doses of etoposide with a less than 50%
- •decrease in serum ferritin 72 hours after last dose, OR
- •c. On a case-by-case basis as determined by the Medical Monitor
- •Type of Participant and Disease Characteristics (Cohort 2 as of
- •amendment 4, Cohort 3-4)
- •1. Treatment naïve, OR
- •2. Early refractory sHLH defined as:
- •a. The participant receiving approximately <1 week of any HLH-directed
- •therapy with insufficient clinical or laboratory response judged by
- •investigator at screening, OR
- •b. On a case-by-case basis as determined by the Medical Monitor
- •3. Participants must meet one of the following:
- •a. Participant has an sHLH confirmed diagnosis (inclusive of MAS)
- •based on fulfilling at least 5 of the 8 modified HLH-2004 criteria below.
- •These criteria may have been assessed prior to the screening period.
- •Participants not fulfilling at least 5 of the 8 modified HLH-2004 criteria
- •may be considered on a case-by-case basis if the diagnosis of sHLH is
- •clinically established especially if one of the criterion is a specialized test
- •result that is performed by a reference laboratory and is not yet
- •Clinical Criteria
- •2. Splenomegaly
- •Laboratory Criteria
- •1. Cytopenia (affecting >=2 of 3 lineages in the peripheral blood):
- •Hemoglobin (<90 g/L), Platelet (<100 x 10*9/L), Neutrophil (<1.0 x
- •2. Hypertriglyceridemia and/or hypofibrinogenemia:
- •Fasting triglycerides >=265 mg/dL or >=3.0 mmol/L, fibrinogen <=1.5 g/L
- •Histopathologic Criteria
- •1. Hemophagocytosis in bone marrow or spleen or lymph nodes or liver
- •2. Low or absent NK-cell activity (according to laboratory reference)
- •3. Ferritin >=500 microgram/L (or ng/mL)
- •4. Elevated sCD25 (e.g., soluble CD25, also known as soluble IL-2
- •b. Participants may be diagnosed with malignancy-associated HLH
- •(mHLH) by meeting the optimized HLH inflammatory (OHI) Index of
- •sCD25 >3900 U/mL (or 23,400 in pg/mL) and ferritin >1000 ng /mL
- •(Zoref-Lorenz et al, 2022).
- •Sex and Contraception
- •1. Male or female
- •Contraception use by men or women should be consistent with local
- •regulations regarding the methods of contraception for those
- •participating in clinical studies.
- •2. Female participants must be either of non-reproductive potential (ie.,
- •premenarchal or post menopausal by history with no menses for >=1
- 另有 8 项未显示
排除标准
- •Medical Conditions
- •1. Known or previous treatment for primary HLH.
- •2. Any other significant concurrent, uncontrolled medical condition that
- •in the opinion of the Investigator contraindicates participation in this
- •3. Unknown trigger for sHLH
- •4. Active, relapsed/refractory malignancy for which no suitable
- •therapies are available to treat the malignancy triggering the HLH
- •Prior/Concurrent Therapy
- •1. Allogeneic hemopoietic stem cell transplant (HSCT) within 100 days
- •of the first dose of ELA026.
- •2. Ongoing administration of any therapies used primarily to treat HLH
- •excluding dexamethasone.
- •3. Live or attenuated vaccine received within 6 weeks or bacille
- •Calmette-Guerin (BCG) vaccine within 12 weeks prior to Screening.
- •1. History of hypersensitivity or allergy to dexamethasone.
- •2. History of hypersensitivity or allergy to any components of ELA026.
- •3. Currently breastfeeding.
- •4. Unwilling or unable to comply with trial.
研究者
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