[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631317":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":19,"responsibleParty":20,"collaborators":19,"id":22,"slug":23,"hasResults":24,"nctId":25,"briefTitle":26,"officialTitle":26,"acronym":19,"eligibilityCriteria":27,"healthyVolunteers":24,"sex":28,"minAge":29,"maxAge":19,"enrollmentInfo":30,"targetDuration":19,"studyType":33,"phases":34,"briefSummary":36,"conditions":37,"keywords":39,"overallStatus":49,"whyStopped":19,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":19},{"fullName":5,"class":6},"Cellenkos, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CK0801","EXPERIMENTAL","All enrolled participants receive CK0801 administered intravenously according to the protocol. CK0801 is given as a weight-based dose of 1 x 10\\^7 Tregs\u002Fkg using actual body weight, capped at 100 kg, on Study Day +1.",[13],"Drug: CK0801",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","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\u002Fkg using actual body weight, capped at 100 kg.",[9],null,{"type":21,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100631317","phase-2-ck0801-for-treatment-of-aplastic-anemia-100631317",false,"NCT07499102","CK0801 for Treatment of Aplastic Anemia","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of aplastic anemia\n* Transfusion dependent after at least one prior line of treatment, or intolerance to standard-of-care treatment\n* Female subjects of childbearing potential must have a negative urine or serum pregnancy test\n* Agrees to comply with all protocol-required procedures, including study-related assessments, visits, and long-term follow-up\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Known HIV seropositivity\n* Uncontrolled infection not responding to appropriate antimicrobial agents after 7 days of therapy; the Protocol PI is the final arbiter of eligibility\n* Uncontrolled intercurrent illness that, in the opinion of the investigator, would place the subject at greater risk of severe toxicity and\u002For impair the activity of CK0801\n* Pregnant or breastfeeding\n* Unable to provide consent or, in the opinion of the investigator, unlikely to fully comply with protocol requirements","ALL","18 Years",{"count":31,"type":32},12,"ESTIMATED","INTERVENTIONAL",[35],"PHASE2","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.",[38],"Aplastic Anemia",[38,40,9,41,42,43,44,45,46,47,48],"Bone Marrow Failure","Regulatory T Cells","Treg Cell Therapy","Cord Blood-Derived Tregs","Allogeneic Cell Therapy","Transfusion Dependent","Immune Dysregulation","Open-Label Phase 2 Study","Cord Blood Unit","NOT_YET_RECRUITING","2026-03-30",{"date":52,"type":53},"2026-04-03","ACTUAL",{"date":55,"type":32},"2026-08-03",{"date":57,"type":32},"2029-08-03",{"name":5,"class":6}]