T Cell MalignanciesPhase 1NCT07465835
A Study of ELA026 in Participants With Relapsed/Refractory (R/R) T/NK Cell Malignancies (TCMs)
A Phase 1 study testing ELA026 in people with T Cell Malignancies, run by Electra Therapeutics Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T Cell Malignancies
- What is being tested?
- ELA026
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 6 sitesUnited States
- Study dates
- 17 Feb 2026to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Trials Electra Clinical Trials Information contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Recruiting
START, Midwest
Grand Rapids, Michigan, 49546
- Recruiting
MD Anderson
Houston, Texas, 77030
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06520
- Recruiting
Memorial Sloan Kettering
New York, New York, 10065
About this study
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.
Read the 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
- Conditions
- T Cell Malignancies
- Being tested
- ELA026
- Keywords
- T cell Malignancies, Lymphoma, SIRP protein, ELA026
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELA026Drug
Weekly maintenance dosing via subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Level 0 Arm | Experimental | Starting dose level Receives: Drug: ELA026 |
| Level -1 Arm | Experimental | Dose level below Starting Dose Level Receives: Drug: ELA026 |
| Level +1 Arm | Experimental | Dose level above Starting Dose Level Receives: Drug: ELA026 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLTs and treatment emergent adverse events (TEAEs), including serious adverse advents (SAEs)
Incidence of DLTs and treatment emergent adverse events (TEAEs), including serious adverse advents (SAEs)
Measured: 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 outcomes (3)
Objective response rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants who achieve a documented complete response (CR) or partial response (PR)
Measured: To be assessed at 8 weeks, 16 weeks and 24 weeks after enrollment
Duration of response (DOR)
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
Measured: Up to two years
Disease control rate (DCR)
Disease control rate (DCR) defined as the proportion of participants with CR, PR, or stable disease (SD)
Measured: Up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start17 Feb 2026
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T Cell MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Electra Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465835
- Sponsor's protocol ID
- ELA026-CP003
- Status last verified
- Jul 2026
- First submitted
- 4 Mar 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of ELA026 in Participants With Relapsed/Refractory (R/R) T/NK Cell Malignancies (TCMs)
- ClinicalTrials.gov ID
- NCT07465835
- Acronym / sponsor ID
- ELA026-CP003
- Conditions
- T Cell Malignancies
- Keywords
- T cell Malignancies, Lymphoma, SIRP protein, ELA026
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Electra Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Level 0 Arm | Experimental | Drug: ELA026Starting dose level |
| Level -1 Arm | Experimental | Drug: ELA026Dose level below Starting Dose Level |
| Level +1 Arm | Experimental | Drug: ELA026Dose level above Starting Dose Level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELA026Weekly maintenance dosing via subcutaneous injection | Drug | Level +1 Arm, Level -1 Arm, Level 0 Arm |
Primary outcome
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)
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for T Cell Malignancies
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Secondary Malignancies of T-cell Origin
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trials Electra Clinical Trials Information contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ELA026 in people with T Cell Malignancies, run by Electra Therapeutics Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Electra Clinical Trials Information (Please email, clinicaltrials@electra-therapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.