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Open-label Study of ELA026 in Participants with sHLH (short title)
EU CTIS ID: 2025-520624-25-00
What this study is testing
Cohort A: To determine 56-day survival with ELA026 treatment in participants with mHLH who are TN and have lymphoma as the cancer trigger
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age and disease
- 2. Adequate organ function that in consideration of the underlying disease trigger and HLH would support enrollment in a clinical trial
- 3. Must be Eastern Cooperative Oncology Group (ECOG) ≤3
- 4.Cohort A and Cohort B: Participant or legally authorized representative(s) (LAR) capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. ICF must be signed prior to initiation of any study related activities unless assessments are conducted as part of routine SOC as indicated in the screening SoA
- 5.Cohort B: Minor participants must be capable of giving written assent as appropriate per the applicable age (per local regulatory requirements). Participant or LAR capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. ICF must be signed prior to initiation of any study related activities.
You likely can't join if
- 1. Refractory sHLH (exception is the safety lead-in cohort for 6 to 12 year olds with refractory sHLH in Cohort B)
- 2. Known or suspected primary or hereditary HLH
- 3. Severe organ dysfunction (see protocol for the list)
- 4. Any other significant concurrent, uncontrolled medical condition that contraindicates participation in this study or prohibits completion of study procedures
- 5. End-stage malignancy for which no suitable therapies are available to treat the malignancy triggering the HLH (participants with refractory malignancy with ongoing therapeutic options are not excluded)
- 6. History of hypersensitivity or allergy to dexamethasone
See the full eligibility criteria
- 1. Age and disease
- 2. Adequate organ function that in consideration of the underlying disease trigger and HLH would support enrollment in a clinical trial
- 3. Must be Eastern Cooperative Oncology Group (ECOG) ≤3
- 4.Cohort A and Cohort B: Participant or legally authorized representative(s) (LAR) capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. ICF must be signed prior to initiation of any study related activities unless assessments are conducted as part of routine SOC as indicated in the screening SoA
- 5.Cohort B: Minor participants must be capable of giving written assent as appropriate per the applicable age (per local regulatory requirements). Participant or LAR capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. ICF must be signed prior to initiation of any study related activities.
- 1. Refractory sHLH (exception is the safety lead-in cohort for 6 to 12 year olds with refractory sHLH in Cohort B)
- 2. Known or suspected primary or hereditary HLH
- 3. Severe organ dysfunction (see protocol for the list)
- 4. Any other significant concurrent, uncontrolled medical condition that contraindicates participation in this study or prohibits completion of study procedures
- 5. End-stage malignancy for which no suitable therapies are available to treat the malignancy triggering the HLH (participants with refractory malignancy with ongoing therapeutic options are not excluded)
- 6. History of hypersensitivity or allergy to dexamethasone
- 7. History of hypersensitivity or allergy to any components of ELA026
- 8. Ongoing social, psychological, religious or spiritual beliefs, or logistical issues that would prevent following study procedures or receiving supportive care to receive study treatment safely please see the protocol for whole list.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.