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NOT YET RECRUITING
NCT07499102
PHASE2

CK0801 for Treatment of Aplastic Anemia

Sponsor: Cellenkos, Inc.

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-08-03

Completion Date

2029-08-03

Last Updated

2026-04-03

Healthy Volunteers

No

Conditions

Interventions

DRUG

CK0801

CK0801 is an investigational allogeneic, cord blood-derived regulatory T-cell product administered by intravenous infusion. The planned dose is 1 x 10\^7 CK0801 Tregs/kg using actual body weight, capped at 100 kg.