A Study of ELA026 in Participants With Relapsed/Refractory (R/R) T/NK Cell Malignancies (TCMs)

May 17, 2026 updated by: Electra Therapeutics Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale New Haven Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • START, Midwest
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Level 0 Arm
Starting dose level
Drug: ELA026
Weekly maintenance dosing via subcutaneous injection
Experimental: Level -1 Arm
Dose level below Starting Dose Level
Drug: ELA026
Weekly maintenance dosing via subcutaneous injection
Experimental: Level +1 Arm
Dose level above Starting Dose Level
Drug: ELA026
Weekly maintenance dosing via subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Incidence of 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: To be assessed at 8 weeks, 16 weeks and 24 weeks after enrollment
Objective response rate (ORR) is defined as the proportion of participants who achieve a documented complete response (CR) or partial response (PR)
To be assessed at 8 weeks, 16 weeks and 24 weeks after enrollment
Duration of response (DOR)
Time Frame: Up to two years
Duration of response (DOR) defined as the time from the first documentation of CR or PR to the first documentation of disease progression or death due to any cause on study, whichever occurs first
Up to two years
Disease control rate (DCR)
Time Frame: Up to two years
Disease control rate (DCR) defined as the proportion of participants with CR, PR, or stable disease (SD)
Up to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Electra Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELA026-CP003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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