CK0801 for Treatment of Aplastic Anemia
ConditionAplastic Anemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCellenkos, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Age 18 years or older
Diagnosis of aplastic anemia
Transfusion dependent after at least one prior line of treatment, or intolerance to standard-of-care treatment
Female subjects of childbearing potential must have a negative urine or serum pregnancy test
Disqualifiers
Known HIV seropositivity
Uncontrolled infection not responding to appropriate antimicrobial agents after 7 days of therapy; the Protocol PI is the final arbiter of eligibility
Uncontrolled intercurrent illness that, in the opinion of the investigator, would place the subject at greater risk of severe toxicity and/or impair the activity of CK0801
Pregnant or breastfeeding
Trial design
Treatments tested in this trial
- CK0801
Treatment groups
12 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov