[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cellenkos, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":115},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,79],{"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":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":15,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":20,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100631317","phase-2-ck0801-for-treatment-of-aplastic-anemia-100631317","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","18 Years",{"count":18,"type":19},[23],"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.",[59],"Aplastic Anemia",[59,61,62,63,64,65,66,67,68,69,70],"Bone Marrow Failure","CK0801","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","2026-03-30",{"date":73,"type":40},"2026-04-03",{"date":75,"type":19},"2026-08-03",{"date":77,"type":19},"2029-08-03",{"name":46,"class":47},{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":15,"minAge":54,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":20,"phases":89,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"100471808","phase-1-leading-in-mpns-beyond-ruxolitinib-in-combo-with-t-regs-100471808","NCT05423691","Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs","Phase Ib, Open-label Study of Add on Therapy With CK0804 in Participants With Myelofibrosis, With Suboptimal Response to Ruxolitinib","TREG108","Inclusion Criteria:\n\n1. Ability to comprehend and willingness to sign a written informed consent form (ICF) for the study.\n2. Age above 18 years inclusive at the time of signing the ICF.\n3. Participants who fulfill the diagnostic criteria of myelofibrosis including primary myelofibrosis and myelofibrosis arising from polycythemia vera and essential thrombocythemia\n4. Life expectancy is greater than 6 months.\n5. Subject has been receiving ruxolitinib therapy, is unlikely to benefit from further ruxolitinib monotherapy in the opinion of the investigator; AND meeting the following criteria: receiving ruxolitinib \\>3 months prior to enrollment; AND stable dose for 8 weeks before starting therapy with CK0804\n6. Subject with evidence of evaluable residual burden of disease following ruxolitinib monotherapy treatment, consisting of:\n\n   * presence of grade ≥2 anemia or thrombocytopenia or neutropenia, OR\n   * presence of disease-related symptoms, as determined by a Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN SAF TSS) score of ≥10 points, OR\n   * documented splenomegaly of at least 5 cm below the costal margin as measured by physical examination or splenomegaly as documented by ultrasound or MRI.\n7. Willingness to avoid pregnancy or fathering children based on the criteria below\n\n   * Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 90 days after the last study treatment dose and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing should be communicated to the participants and their understanding confirmed.\n   * Women of childbearing potential must have a negative serum pregnancy test at screening before the first dose (within 3 days of the first study treatment dose) and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through the safety follow-up visit and must not donate oocytes during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed,\n   * Women of nonchildbearing potential (ie, surgically sterile with a hysterectomy and\u002For bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 50 years of age) are eligible.\n8. ECOG performance status of 0 to 2\n\nExclusion Criteria:\n\n1. Any major surgery within 28 days before the first dose of study treatment.\n2. Undergone any prior allogenic or autologous stem cell transplantation or a candidate for such transplantation.\n3. Received chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody or hypomethylating agent to treat the participant's disease, with the exception of ruxolitinib, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.\n4. Participant has received splenic irradiation within the past 6 months.\n5. Significant concurrent, uncontrolled medical condition or infections, which in the opinion of the principal investigator may interfere in the study participation.\n6. Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.\n7. Women who are pregnant or breastfeeding.\n8. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n9. Participants with laboratory values at screening as defined\n\n   * Platelets \\\u003C 50 × 10\\^9\u002FL without the assistance of growth factors, thrombopoietic factors, or platelet transfusions\n   * ANC \\\u003C 0.5 × 10\\^9\u002FL\n   * ALT ≥ 2.5 × ULN\n   * AST ≥ 2.5 × ULN\n   * Direct Bilirubin \\> 2.0 × ULN\n   * ALP ≥ 3 × ULN\n   * Creatinine clearance \\\u003C 50 mL\u002Fmin according to Cockcroft-Gault formula.\n10. Unwillingness to be transfused with blood components including RBC and platelet transfusions.\n11. Inability of the participant (or parent, guardian, or legally authorized representative) to comprehend the ICF or unwillingness to sign the ICF.",{"count":88,"type":19},24,[22],"To assess the safety and tolerability of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib",[92],"Myelofibrosis",[94,95,96,34,97,98,99,100,101,102,103,104],"myelofibrosis","ruxolitinib","CK0804","cord blood unit","allogeneic","Treg Cells","Bone Marrow Diseases","Hematologic Diseases","Bone Marrow Neoplasms","Myeloproliferative Disorders","Thrombocytosis","RECRUITING","2025-04-10",{"date":108,"type":40},"2025-04-13",{"date":110,"type":40},"2022-12-27",{"date":112,"type":19},"2026-12-30",{"name":46,"class":47},4,""]