CK0801 for Treatment of Aplastic Anemia

This Phase 2, multicenter, open-label study is evaluating CK0801 for the treatment of aplastic anemia in adults with persistent transfusion dependence after at least one prior line of therapy or intolerance to standard-of-care treatment. CK0801 is an allogeneic cord blood-derived regulatory T-cell therapy administered intravenously. The study is designed to assess safety and clinical activity, including hematologic response, transfusion independence, duration of response, survival outcomes, and patient-reported outcomes. Exploratory assessments include immune reconstitution, biomarkers, pharmacokinetics, immunogenicity, and donor-specific antibodies. The primary endpoint is overall response at Day 180.

NCT Number	NCT07499102
Lead Sponsor	Cellenkos, Inc.
Conditions	Aplastic Anemia
Enrollment	12 participants
Start Date	2026-08-03
Primary Completion	2028-08-03 (estimated)
Study Completion	2029-08-03 (estimated)
Updated on ClinicalTrials.gov	2026-04-03