Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

MI-összefoglaló

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The trial is looking for people aged 6 years and older with secondary hemophagocytic lymphohistiocytosis (sHLH). sHLH is a rare, life-threatening overreaction of the immune system, often triggered by cancer, infection or autoimmune disease.

Életkor

6 years and older. In Part 1, Cohort 1 needs age 12 years or more at HLH diagnosis, and Cohorts 2-3 need age 6 years or more. Part 2 takes adults, 13 to 17 year olds and 6 to 12 year olds.

Nem

All sexes can join.

A betegség stádiuma

Part 1: sHLH meeting 5 out of 8 HLH-2004 diagnostic criteria. It can be untreated or relapsed/refractory (Cohorts 1 and 2), or untreated or early refractory (Cohort 3). Part 2: newly diagnosed sHLH, linked to cancer or not. Refractory sHLH only in the 6 to 12 year old safety lead-in group.

Korábbi kezelés

Part 2 mostly needs people with no earlier treatment for sHLH. Part 1 also takes people whose disease came back or did not respond to treatment. People cannot be taking other HLH treatments during the trial, except dexamethasone.

Biomarker vagy leletérték

In Part 1, sHLH must meet 5 out of 8 HLH-2004 diagnostic criteria. In Part 2, some adults with cancer-linked sHLH are diagnosed by the OHI index.

A részvétel fő kizáró okai

• Known or suspected primary or hereditary HLH, or past treatment for primary HLH
• Unknown trigger for the sHLH (Part 1)
• Active or end-stage cancer that triggers the HLH, with no available treatment for it
• Donor stem cell transplant (allogeneic HSCT) within 100 days of the first dose (Part 1) or within 30 days before joining (Part 2)
• Severe organ problems or another serious uncontrolled illness; live or weakened vaccine within 6 weeks, or BCG vaccine within 12 weeks, before screening

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

Hemophagocytic lymphohistiocytosis is a rare, aggressive and life-threatening syndrome of excessive immune activation. Secondary hemophagocytic lymphohistiocytosis (sHLH) is the most common form of this disease and is typically associated with several other clinical conditions (eg, malignancy associated HLH (mHLH), infection, or autoimmune disease). ELA026 is a fully human immunoglobulin G1 (IgG1) signal regulatory protein (SIRP)-directed monoclonal antibody designed to deplete the myeloid and T cells driving the inflammation. The purpose of this study is to assess the safety, efficacy pharmacokinetics and pharmacodynamics of ELA026 in participants with sHLH.

A vizsgálat 2 csoportja

• Part 1 ELA026A vizsgált kezelés

  Cohort 1: Single dose escalation up to 3.0 mg/kg IV or SC. Cohort 2: priming dose: 0.1 mg/kg IV on Day 1; 0.3 mg/kg IV on Day 2 - 4, followed by weekly maintenance doses of 1 mg/kg IV/SC from Day 8 to Day 81. Cohort 3: priming dose: 0.1 mg/kg IV on Day 1; 0.3 mg/kg IV on Days 2 - 4, followed by twice weekly maintenance doses of 0.5 mg/kg IV/SC from Day 8 to Day 81.

  Kezelés: ELA026

• Part 2 ELA026A vizsgált kezelés

  Cohort A and Cohort B: priming dose: 0.1 mg/kg IV/SC on Day 1; loading dose 0.3 mg/kg IV/SC on Days 2 - 4, followed by twice weekly maintenance doses of 0.5 mg/kg (IV/SC) from Day 8 to Day 81.

  Kezelés: ELA026