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A Study of ELA026 in Participants With Relapsed/Refractory (R/R) T/NK Cell Malignancies (TCMs)
Trial Status: active
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.
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07465835.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital Midtown
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available
Texas
Houston
UT MD Anderson Cancer Center
Status: Approved
Name Not Available
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
