[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641053":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":33,"acronym":20,"eligibilityCriteria":34,"healthyVolunteers":31,"sex":35,"minAge":36,"maxAge":20,"enrollmentInfo":37,"targetDuration":20,"studyType":40,"phases":41,"briefSummary":44,"conditions":45,"keywords":47,"overallStatus":56,"whyStopped":20,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":20},{"fullName":5,"class":6},"Cellenkos, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Arm","EXPERIMENTAL","CK0802 Tregs will be administered intravenously at a fixed dose of 100 million Treg cells.",[13],"Biological: CK0802 (Allogeneic, Cryopreserved, Cord blood-derived T-regulatory cells, cells that are not HLA matched)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","CK0802 (Allogeneic, Cryopreserved, Cord blood-derived T-regulatory cells, cells that are not HLA matched)","Subjects will receive seven planned doses of CK0802 on study day +1, +3 (+\u002F-1 day), +5 (+\u002F-1 day), +7 (+\u002F- 2 day), +14 (+\u002F- 3 days), +21 (+\u002F-3 days) and +28 (+\u002F-3 days). A total of 7 doses will be administered.\n\nIf Day 29 assessment shows PR or MR, then 4 additional weekly infusion of CK0802 Tregs can be administered (study days: 35 (+\u002F- 2 day), 42 (+\u002F- 2 day), 49 (+\u002F- 2 day), and 55(+\u002F- 2 day)), for a total of 11 infusions",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Clinical Trial Specialist","CONTACT","8002178247","contact@cellenkosinc.com",{"type":28,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100641053","phase-1-ck0802-for-treatment-of-steroid-refractory-graft-vs-host-disease-gvhd-100641053",false,"NCT07576699","CK0802 for Treatment of Steroid Refractory Graft vs. Host Disease (GVHD)","Inclusion Criteria:\n\n* 1\\. Age ≥12 years old (first 3 subjects will be ≥ 18 years)\n* 2\\. Grade 2-4 acute GVHD (aGVHD) at baseline\n* 3\\. No other prior aGVHD treatment\n* 4\\. Steroid Refractory\n* Progressed after 3 days of treatment with 2 mg\u002Fkg methylprednisolone (MPE)\n* No improvement after 7 days of treatment with 2 mg\u002Fkg MPE\n* Progressed to a new organ after treatment with 1 mg\u002Fkg MPE for skin or upper gastrointestinal (UGI) aGVHD\n* Progressed from nadir during or after a steroid taper\n* 5\\. Female subjects of childbearing potential (FPCP) must have a negative urine or serum pregnancy test.\n* 6\\. Agreed to abide by all protocol required procedures including study-related assessments, visits and long term follow up.\n* 7\\. Willing and able to provide written informed consent.\n* 8\\. Signed informed consent\n\nExclusion Criteria:\n\n* 1\\. 30 days prior treatment with any other investigational agent after allogeneic HSCT.\n* 2\\. Known HIV seropositivity.\n* 3\\. Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.\n* 4\\. Subjects with uncontrolled inter-current illness that in the opinion of the investigator would place the subject at greater risk of severe toxicity and\u002For impair the activity of CK0802.\n* 5\\. Subjects who are pregnant or breastfeeding.","ALL","12 Years",{"count":38,"type":39},12,"ESTIMATED","INTERVENTIONAL",[42,43],"PHASE1","PHASE2","The purpose of this study is to determine the efficacy and safety of CK0802 Tregs for treatment of refractory GVHD (graft-versus-host disease)",[46],"Steroid Refractory Graft Versus Host Disease",[48,49,50,51,52,53,54,55],"gvhd","Tregs","graft vs. host disease","steroid refractory","steroid refractory GVHD","CK0802","T regulatory cells","CK0802 Tregs","NOT_YET_RECRUITING","2026-05-07",{"date":59,"type":60},"2026-05-11","ACTUAL",{"date":62,"type":39},"2026-07-01",{"date":64,"type":39},"2029-06-30",{"name":5,"class":6}]