A Study of ELA026 in Participants With Relapsed/Refractory (R/R) T/NK Cell Malignancies (TCMs)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ELA026.
- Who it may be relevant to
- Registry conditions: T Cell Malignancies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
This is the first clinical study of ELA026 as a therapy for R/R TCMs. The study will begin with an initial dose finding component (Part 1, Phase 1a), enrolling approximately 6 to 18 participants (up to maximum of 24 participants) to identify up to 2 dosing regimens with an acceptable safety profile. Upon completion of Part 1, the study will proceed to the cohort expansion phase (Part 2, Phase 1b) to further evaluate these regimens.
Parts 1 and 2 will include the following study periods:
* Screening period: up to 28 days * Treatment period: up to 6 cycles or 24 weeks (1 cycle = 28 days) * Optional extension period: On a case-by-case basis, participants experiencing ongoing clinical benefits may continue treatment beyond 6 cycles, up to an additional 6 cycles, with approval by the Sponsor * Safety follow-up: 28 days after the last dose of study treatment * Survival follow-up: up to 2 years from the end of treatment
Interventions
- Drug ELA026
Weekly maintenance dosing via subcutaneous injection
Primary outcome measures
- DLTs and treatment emergent adverse events (TEAEs), including serious adverse advents (SAEs) [Time frame: 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)]
Secondary outcome measures (3)
- Objective response rate (ORR) [Time frame: To be assessed at 8 weeks, 16 weeks and 24 weeks after enrollment]
- Duration of response (DOR) [Time frame: Up to two years]
- Disease control rate (DCR) [Time frame: Up to two years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- Yale New Haven Hospital — New Haven
- Emory University Hospital — Atlanta
- START, Midwest — Grand Rapids
- Memorial Sloan Kettering — New York
- University Hospitals Cleveland Medical Center — Cleveland
- MD Anderson — Houston
Identifiers
NCT: NCT07465835 · ELA026-CP003