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

ConditionT Cell Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorElectra Therapeutics Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Sequential

Treatments tested in this trial

  • ELA026

    Drug

    Weekly maintenance dosing via subcutaneous injection

Treatment groups

84 Participants
are divided into 3 treatment groups
Group A: Level 0 ArmExperimental treatment 1 intervention
Group B: Level -1 ArmExperimental treatment 1 intervention
Group C: Level +1 ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

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)

Secondary outcomes

1

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)

Time frame
To be assessed at 8 weeks, 16 weeks and 24 weeks after enrollment
2

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

Time frame
Up to two years
3

Disease control rate (DCR)

Disease control rate (DCR) defined as the proportion of participants with CR, PR, or stable disease (SD)

Time frame
Up to two years

Other outcomes

Sponsors and contacts

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Electra Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov
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