A Global Phase 2/3 Open-Label Study of Ipsoprubart in Treatment-Naïve Adult and Pediatric Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Key Objectives of SURPASS
SURPASS is a global open-label, single-arm, multi-center, external-controlled Phase 2/3 registrational trial evaluating ipsoprubart in adult and pediatric patients with newly-diagnosed, treatment-naïve sHLH, a rare, life-threatening condition marked by excessive immune activation.1 The trial is designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of ipsoprubart.
About Ipsoprubart
Ipsoprubart is a pan-SIRP (SIRPα/β1/γ) monoclonal antibody designed to selectively deplete activated T cells and myeloid cells that are believed to be key drivers of the hyperinflammatory response in sHLH.
Ipsoprubart is formulated for intravenous (IV) or subcutaneous (SC) injection.
| Study Day | Dose | Dosing Method |
|---|---|---|
| 1 | 0.1 mg/kg | IV |
| 2 | 0.3 mg/kg | IV |
| 3 | 0.3 mg/kg | IV |
| 4 | 0.3 mg/kg | IV |
| 2x per week starting at Day 8 | 0.5 mg/kg | IV or SC |
Reference: 1. Konkol S, Killeen RB, Rai M. Hemophagocytic Lymphohistiocytosis. [Updated 2025 May 3]. In: StatPearls [Internet]. Treasure Island, FL: StatPearls Publishing; 2025 Jan. https://www.ncbi.nlm.nih.gov/books/NBK557776/
Key Inclusion Criteria
Cohort A
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Adults with treatment-naïve, malignancy-associated HLH |
Cohort B
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Adults with treatment-naïve sHLH not triggered by malignancy |
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Adults with treatment-naïve, malignancy-triggered HLH, diagnosed by Optimized HLH Inflammatory (OHI) Index1 but not meeting HLH-2004 criteria |
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Pediatric patients aged 6 to 17 years with newly diagnosed sHLH of any trigger, with enrollment of patients aged 6 to 12 years governed by a safety lead-in cohort |
Diagnosis of HLH will be confirmed by participants meeting five of eight HLH-2004 criteria, except where noted.
Reference: 1. Zoref-Lorenz A, Murakami J, Hofstetter L, et al. An improved index for diagnosis and mortality prediction in malignancy-associated hemophagocytic lymphohistiocytosis. Blood. 2022;139(7):1098-1110. doi:10.1182/blood.2021012764
Key Exclusion Criteria
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Refractory sHLH (except for safety lead-in cohort for 6-12 years old in Cohort B) |
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Known or suspected primary or hereditary HLH |
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Severe organ dysfunction |
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Any other significant concurrent, uncontrolled medical condition that contraindicates participation in this study or prohibits completion of study procedures |
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End-stage malignancy for which no suitable therapies are available to treat the malignancy triggering the HLH |
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Allogeneic hematopoietic stem cell transplant within 100 days prior to the first dose of Ipsoprubart (ELA026) |
Clinical Trial Summary
SURPASS is a global open-label, single-arm, multicenter, external-controlled Phase 2/3 registrational trial that evaluates ipsoprubart (ELA026) in adult and pediatric patients aged ≥6 years with sHLH.a
The primary objective of the study is to assess the effect of ipsoprubart on 8-week survival in treatment-naïve lymphoma-associated HLH participants.
Secondary objectives include other efficacy parameters, safety, healthcare outcomes, pharmacokinetics, and pharmacodynamics.
Download the SURPASS study one-page summary below.