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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Level 0 Arm | Experimental | Starting dose level |
|
| Level -1 Arm | Experimental | Dose level below Starting Dose Level |
|
| Level +1 Arm | Experimental | Dose level above Starting Dose Level |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELA026 | Drug | Weekly maintenance dosing via subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | To be assessed at 8 weeks, 16 weeks and 24 weeks after enrollment |
| Duration of response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Electra Clinical Trials Information | Contact | Please email | clinicaltrials@electra-therapeutics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | Recruiting | New Haven | Connecticut | 06520 | United States | |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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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) | Disease control rate (DCR) defined as the proportion of participants with CR, PR, or stable disease (SD) | Up to two years |
| Emory University Hospital |
| Recruiting |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| START, Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States |
| Memorial Sloan Kettering | Recruiting | New York | New York | 10065 | United States |
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
| MD Anderson | Recruiting | Houston | Texas | 77030 | United States |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |