A Study of ELA026 in Participants With Relapsed/Refractory (R/R) T/NK Cell Malignancies (TCMs)
Start Date
2/17/2026
Completion Date
12/1/2028
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
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ELA026
Conditions
Locations
Yale New Haven Hospital
New Haven, Connecticut 06520
United States
Emory University Hospital
Atlanta, Georgia 30322
United States
START, Midwest
Grand Rapids, Michigan 49546
United States
Memorial Sloan Kettering
New York, New York 10065
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
MD Anderson
Houston, Texas 77030
United States