ELA026: Weekly maintenance dosing via subcutaneous injection
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion 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 CTCL) and eligible for investigational therapies
* 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
Exclusion Criteria:
* 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 cell death ligand 1 \[PD-L1\] inhibitors)
* 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 drug
Primary outcome measure(s)
DLTs and treatment emergent adverse events (TEAEs), including serious adverse advents (SAEs) — DLTs from baseline to DLT window (35 days) and SAEs from baseline through end of safety follow up (approximately 28 weeks for those participants not continuing to optional extension phase) Incidence of DLTs and treatment emergent adverse events (TEAEs), including serious adverse advents (SAEs)
Trial sites (6)
Facility
City
Region
Status
Yale New Haven Hospital
New Haven
Connecticut
Recruiting
Emory University Hospital
Atlanta
Georgia
Recruiting
START, Midwest
Grand Rapids
Michigan
Recruiting
Memorial Sloan Kettering
New York
New York
Recruiting
University Hospitals Cleveland Medical Center
Cleveland
Ohio
Recruiting
MD Anderson
Houston
Texas
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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