ELA026 for adults with relapsed or refractory T-cell and NK-cell cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Yale New Haven Hospital
  New Haven, Connecticut, United States Recruiting
• Emory University Hospital
  Atlanta, Georgia, United States Recruiting
• START, Midwest
  Grand Rapids, Michigan, United States Recruiting
• Memorial Sloan Kettering
  New York, New York, United States Recruiting
• University Hospitals Cleveland Medical Center
  Cleveland, Ohio, United States Recruiting
• MD Anderson
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Electra Clinical Trials Information
• Email: clinicaltrials@electra-therapeutics.com
• Phone: Please email

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.