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New treatment option for T Cell Malignancies
Official title A Study of ELA026 in Participants With Relapsed/Refractory (R/R) T/NK Cell Malignancies (TCMs)
ClinicalTrials.gov ID: NCT07465835
What this study is testing
What is ELA026?
ELA026 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for t cell malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1, two-part, multicenter study to evaluate ELA026 in participants ≥18 years old with relapsed/refractory TCM following any line of prior therapy who are eligible for investigational treatments.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years Participants with a confirmed histologic diagnosis of a TCM who are R/R following any line of prior therapy (participants with CTCLs...
- Presence of measurable disease by clinical examination, radiologic imaging (computed tomography, magnetic resonance imaging, or whole body FDG-PET...
- Eastern Cooperative Oncology Group performance score of ≤2
- Anticipated life expectancy \>6 months per investigator judgment
You likely can't join if
- Participants who are eligible for standard of care or approved therapeutic options for R/R TCMs with established clinical benefit
- Organ dysfunction as defined in the protocol
- Participants with hemophagocytic lymphohistiocytosis (HLH) based on HLH2004 diagnostic criteria
- Participants receiving or planning to start immunotherapy or immune effector cell therapy (such as chimeric antigen receptor [CAR] T-cell therapy...
- Allogeneic hemopoietic stem cell transplant within 100 days prior to the first dose of ELA026 and currently receiving systemic immunosuppressive...
- Women of childbearing potential who are planning to become pregnant or are breastfeeding during the conduct of the study, including 60 days after...
See the full eligibility criteria
- Age ≥18 years Participants with a confirmed histologic diagnosis of a TCM who are R/R following any line of prior therapy (participants with CTCLs should have received at least 2 prior lines of systemic therapy for R/R...
- Presence of measurable disease by clinical examination, radiologic imaging (computed tomography, magnetic resonance imaging, or whole body FDG-PET scans), and/or in bone marrow aspirate/biopsy
- Eastern Cooperative Oncology Group performance score of ≤2
- Anticipated life expectancy \>6 months per investigator judgment
- Participants who are eligible for standard of care or approved therapeutic options for R/R TCMs with established clinical benefit
- Organ dysfunction as defined in the protocol
- Participants with hemophagocytic lymphohistiocytosis (HLH) based on HLH2004 diagnostic criteria
- Participants receiving or planning to start immunotherapy or immune effector cell therapy (such as chimeric antigen receptor [CAR] T-cell therapy, T-cell engagers, or programmed cell death protein 1 [PD1]/programmed...
- Allogeneic hemopoietic stem cell transplant within 100 days prior to the first dose of ELA026 and currently receiving systemic immunosuppressive therapy
- Women of childbearing potential who are planning to become pregnant or are breastfeeding during the conduct of the study, including 60 days after last dose of study drug
- Male participants whose partners are women of childbearing potential and who are planning to become pregnant during the conduct of this trial by the male partner, including within 60 days after the last dose of study...
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Grand Rapids, Michigan, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Houston, Texas, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Atlanta, Georgia, United States; Grand Rapids, Michigan, United States; New York, New York, United States; Cleveland, Ohio, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.