[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"steroid-refractory-graft-versus-host-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:steroid-refractory-graft-versus-host-disease":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"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":18,"type":19},12,"ESTIMATED","INTERVENTIONAL",[22,23],"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)",[26],"Steroid Refractory Graft Versus Host Disease",[28,29,30,31,32,33,34,35],"gvhd","Tregs","graft vs. host disease","steroid refractory","steroid refractory GVHD","CK0802","T regulatory cells","CK0802 Tregs","NOT_YET_RECRUITING","2026-05-07",{"date":39,"type":40},"2026-05-11","ACTUAL",{"date":42,"type":19},"2026-07-01",{"date":44,"type":19},"2029-06-30",{"name":46,"class":47},"Cellenkos, Inc.","INDUSTRY",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":20,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100419622","early-phase-1-addition-of-cord-blood-tissue-derived-mesenchymal-stromal-cells-to-ruxolitinib-for-the-treatment-of-steroid-refractory-acute-graft-versus-host-disease-100419622","NCT04744116","Addition of Cord Blood Tissue-Derived Mesenchymal Stromal Cells to Ruxolitinib for the Treatment of Steroid-Refractory Acute Graft Versus Host Disease","A Randomized Controlled Pilot Study of Two Doses of Cord Blood Tissue-Derived Mesenchymal Stromal Cells Combined With Ruxolitinib Versus Ruxolitinib Alone for Therapy of Steroid-Refractory Acute Graft Versus Host Disease","Inclusion Criteria:\n\n1. Participants between the ages of 12 years and 80 years (inclusive).\n2. Steroid refractory grades II-IV acute GVHD of the Lower GI tract or Liver (including those developing these manifestations after previous acute GVHD of skin) secondary to allogeneic HCT or donor lymphocyte infusion. (Grading, see Appendix I) GVHD with: No improvement after treatment with methylprednisolone at ≥ 2.0 mg\u002Fkg\u002Fday or equivalent for minimum 7 days, or progressive symptoms after minimum 3 days, or a flare in acute GVHD while on systemic steroids. Participants must have had a biopsy that suggests GVHD; a repeat biopsy to enroll on the study is not necessary.\n3. Karnofsky\u002FLansky Performance score of at least 30 at the time of study entry.\n4. Participants who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male patients must use adequate contraception\n5. Participants (or legal representative where appropriate) must be capable of providing written informed consent, and assent if indicated.\n\nExclusion Criteria:\n\n1. De novo chronic GVHD\n2. Isolated acute GVHD of skin\n3. Secondary systemic therapy for acute GVHD ruxolitinib greater than 96 hours before initiation of therapy.\n4. Primary treatment with agents other than alpha-1 antitrypsin (AAT) glucocorticoids and ruxolitinib.\n5. Participants with uncontrolled infections will be excluded. Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.\n6. Adult and pediatric patients with cognitive impairments and\u002For any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance with study procedures.\n7. Participants with significant supplemental oxygen requirement defined as \\>6 L oxygen by nasal cannula.\n8. Participants with known allergy to bovine or porcine products.","80 Years",{"count":57,"type":19},24,[59],"EARLY_PHASE1","This early phase I trial is to find out the effect of adding cord blood tissue-derived mesenchymal stromal cells (cb-MSCs) to ruxolitinib in treating patients with acute graft versus host disease that does not respond to steroid therapy (steroid-refractory). Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. cb-MSCs are a type of tissue helper cell that can be removed from donated umbilical cord blood tissue and grown into many different cell types that can be used to treat cancer and other disease, such as graft versus host disease. This trial aims to learn if adding cb-MSCs to ruxolitinib may help control steroid-refractory acute graft versus host disease.",[62,26],"Hematopoietic and Lymphoid Cell Neoplasm","RECRUITING","2026-04-29",{"date":66,"type":40},"2026-05-05",{"date":68,"type":40},"2021-02-17",{"date":70,"type":19},"2032-03-31",{"name":72,"class":73},"M.D. Anderson Cancer Center","OTHER",1,"Steroid Refractory Graft-Versus-Host Disease"]