Recruiting
Phase 1

ELA026

Sponsor:

Electra Therapeutics Inc.

Code:

NCT07465835

Conditions

T Cell Malignancies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ELA026

Study Details

Brief 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.

Conditions

T Cell Malignancies

Study ID

NCT07465835

Start date

Feb 17, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

84 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Level 0 Arm

Starting dose level

experimental: Level -1 Arm

Dose level below Starting Dose Level

experimental: Level +1 Arm

Dose level above Starting Dose Level

Interventions

ELA026

Weekly maintenance dosing via subcutaneous injection

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Clinical Trials Electra Clinical Trials Information

Please emailclinicaltrials@electra-therapeutics.com

Locations

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06520

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

START, Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Memorial Sloan Kettering

Recruiting

New York, New York, United States, 10065

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

MD Anderson

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Electra Therapeutics Inc.

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • T cell Malignancies
  • Lymphoma
  • SIRP protein
  • ELA026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Electra Therapeutics Inc. on 2026-07-08.