ELA026 for adults with relapsed or refractory T-cell and NK-cell cancers
A Study of ELA026 in Participants With Relapsed/Refractory (R/R) T/NK Cell Malignancies (TCMs)
This Phase 1 trial will test whether ELA026 can help adults with relapsed or refractory T/NK cell cancers who have already received prior therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Electra Therapeutics Inc. Industry-sponsored |
| Drugs / interventions | chimeric antigen receptor, immunotherapy |
| Locations | 1 site (Grand Rapids, Michigan) |
| Trial ID | NCT07465835 on ClinicalTrials.gov |
What this trial studies
This is the first clinical study of ELA026 in relapsed/refractory T/NK cell malignancies and is a Phase 1, multicenter, two-part trial. Part 1 is a dose-finding component enrolling about 6 to 18 participants (up to 24) to identify up to two dosing regimens with acceptable safety. Part 2 is a cohort expansion to further evaluate the selected regimens. Treatment is given in cycles up to 6 cycles (24 weeks) with an optional extension for those benefiting, plus a 28-day safety follow-up and survival follow-up for up to two years.
Who should consider this trial
Good fit: Adults (≥18 years) with a confirmed relapsed/refractory T-cell or NK-cell malignancy who have measurable disease, an ECOG performance status of 0–2, anticipated life expectancy over 6 months, and who are eligible for investigational therapies (for CTCL, at least two prior systemic therapies are required).
Not a fit: Patients who are eligible for established standard-of-care or approved therapies with known clinical benefit, those with significant organ dysfunction, active hemophagocytic lymphohistiocytosis (HLH), or those receiving/planning other immunotherapy or immune effector cell treatments are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, ELA026 could offer a new treatment option that controls disease or extends survival for patients with relapsed/refractory T/NK cell malignancies.
How similar studies have performed: This is the first clinical study of ELA026 in these cancers, and SIRP-targeting or related approaches remain early-stage with limited published clinical success in T/NK cell malignancies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Grand Rapids, Michigan
- START, Midwest — Grand Rapids, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Electra Clinical Trials Information
- Email: clinicaltrials@electra-therapeutics.com
- Phone: Please email
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.