T Cell Malignancies
Conditions
Keywords
T cell Malignancies, Lymphoma, SIRP protein, ELA026
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.
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
Interventions
DRUGELA026
Weekly maintenance dosing via subcutaneous injection
Sponsors
Electra Therapeutics Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Incidence of DLTs and treatment emergent adverse events (TEAEs), including serious adverse advents (SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 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) |
| Duration of response (DOR) | 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 |
| Disease control rate (DCR) | Up to two years | Disease control rate (DCR) defined as the proportion of participants with CR, PR, or stable disease (SD) |
Countries
United States
Contacts
CONTACTClinical Trials Electra Clinical Trials Information
Outcome results
None listed