[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dong-A University Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100656716","safety-and-efficacy-of-autologous-natural-killer-cell-therapy-chank-101-in-patients-with-recurrent-glioblastoma-100656716",false,"NCT07831161","Safety and Efficacy of Autologous Natural Killer Cell Therapy (CHANK-101) in Patients With Recurrent Glioblastoma","A Multicenter, Open-label, Externally Controlled Clinical Study to Evaluate the Safety and Efficacy of Autologous Natural Killer Cell (CHANK-101) in Patients With Recurrent Glioblastoma","Inclusion Criteria:\n\n1. Male or female adults aged 19 years to less than 70 years who have received sufficient explanation regarding the purpose, methods, potential benefits, and risks of the study and have voluntarily provided written informed consent.\n2. Histologically confirmed IDH-wildtype glioblastoma (GBM), WHO Grade 4, according to the WHO CNS5 2021 classification.\n3. Completion of standard first-line treatment (surgery + radiotherapy + concurrent TMZ → 6 cycles of adjuvant TMZ).\n4. Confirmed first recurrence, defined by at least one of the following:\n\n(1) Progressive Disease according to RANO 2.0 criteria on MRI more than 12 weeks after completion of radiotherapy.\n\n(2) If within 12 weeks after completion of radiotherapy, pseudoprogression has been excluded through the RANO 2.0 confirmation procedure (confirmatory scan), and persistent progression has been confirmed on two consecutive scans at least 4 weeks apart.\n\n5\\. No antitumor treatment, including chemotherapy, immunotherapy, targeted therapy, or radiotherapy, after confirmation of recurrence, except surgery.\n\n6\\. KPS ≥ 60.\n\n7\\. Adequate organ function permitting study treatment and surgery, including:\n\n1. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL.\n2. Platelets ≥ 100 × 10\\^9\u002FL.\n3. Hemoglobin (Hb) ≥ 9.0 g\u002FdL.\n4. AST and ALT ≤ 2.5 × ULN.\n5. Total bilirubin ≤ 1.5 × ULN.\n6. Serum creatinine ≤ 1.5 × ULN or eGFR ≥ 50 mL\u002Fmin\u002F1.73 m\\^2.\n\n8\\. Adequate peripheral venous access for leukapheresis or ability to undergo central venous catheter placement.\n\n9\\. Life expectancy of at least 12 weeks, as determined by the investigator.\n\n10\\. Female participants who are postmenopausal, defined as 12 months of amenorrhea without a medical cause, or women of childbearing potential with a negative pregnancy test.\n\n11\\. Women of childbearing potential and male participants who agree to use appropriate contraception (e.g., condoms, hormonal contraceptives, oral contraceptives, intrauterine devices, or sterilization) during the study and for 3 months after the last administration of the study treatment.\n\nExclusion Criteria:\n\n1. Two or more recurrences or prior antitumor treatment for a previous recurrence.\n2. Confirmed leptomeningeal dissemination or extracranial metastasis.\n3. Requirement for chronic high-dose systemic corticosteroids (e.g., \\>10 mg\u002Fday prednisolone equivalent) or continuous use of other immunosuppressive drugs. Low-dose corticosteroid use at enrollment is permitted; however, the washout criteria must be met at each study treatment administration.\n4. Active autoimmune disease requiring systemic immunosuppressive treatment within the past 2 years (e.g., steroids ≥10 mg\u002Fday prednisolone equivalent or immunosuppressive agents). Exceptions include adequately treated Basedow\u002FGraves disease or Hashimoto thyroiditis with stable thyroid hormone replacement therapy, vitiligo, resolved childhood asthma, type 1 diabetes, and localized skin disorders.\n5. A positive result for any of the following infectious disease tests performed at screening. However, participants with a positive result may participate if the investigator determines that it has no clinically significant impact on participation in the study:\n\n(1) HBsAg\u002FHBV NAT. (2) HCV Ab\u002FHCV NAT. (3) HIV Ab\u002FHIV NAT. (4) Syphilis (non-treponemal\u002Ftreponemal). (5) HTLV Ab. (6) CMV Ab\u002FCMV NAT.\n\n6\\. Uncontrolled active infection or any other infectious disease considered by the investigator to be inappropriate for participation in the study.\n\n7\\. History of another malignancy within the past 3 years, except adequately treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.\n\n8\\. Contraindication to leukapheresis (e.g., severe cardiovascular disease or coagulation disorder).\n\n9\\. Serious medical or psychiatric condition that may affect participation in the study.\n\n10\\. History of a severe allergic reaction or other serious hypersensitivity to the study treatment or any of its excipients.\n\n11\\. Pregnant or breastfeeding women.\n\n12\\. Participants planning pregnancy during the study.\n\n13\\. Participants considered by the investigator unlikely to comply with study treatment, study procedures, or follow-up.\n\n14\\. Any other participant considered by the investigator to be unsuitable for participation in the study.","ALL","19 Years","69 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","This multicenter, open-label, externally controlled clinical study is designed to evaluate the safety and efficacy of CHANK-101, an autologous natural killer (NK) cell therapy, in patients with recurrent glioblastoma. The primary objective is to evaluate progression-free survival (PFS) following CHANK-101 administration. Secondary objectives include evaluating safety and tolerability, progression-free survival at 6 months (PFS-6), and overall survival (OS).",[27],"Recurrent Glioblastoma",[27,29,30,31],"Autologous Natural Killer Cells","CHANK-101","NK Cell Terapy","NOT_YET_RECRUITING","2026-09-15",{"date":35,"type":36},"2026-09-21","ACTUAL",{"date":38,"type":21},"2026-09-29",{"date":40,"type":21},"2028-03-31",{"name":42,"class":43},"Dong-A University Hospital","OTHER",4,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100509161","phase-2-carfilzomib-oral-cyclophosphamide-and-dexamethasone-for-rrmm-100509161","NCT05909826","Carfilzomib, Oral Cyclophosphamide, and Dexamethasone for RRMM","A Phase II Study of Carfilzomib, Oral Cyclophosphamide, and Dexamethasone for Relapsed and\u002For Refractory Multiple Myeloma","KMM-KCd","Inclusion Criteria:\n\n1. Subjects aged 19 years or older\n2. ECOG performance status 0 to 2\n3. Diagnosed with multiple myeloma by IMWG criteria\n4. Subjects previously treated with 1 or more lines of therapy\n5. Subjects previously treated with lenalidomide-based combination or sigle drug therapy\n6. Subjects with relapsed and\u002For refractory multiple myeloma\n7. Subjects with measurable disease at the time of treatment initiation\n\n   * serum M protein \\>=0.5 g\u002FdL, or\n   * 24h urine M protein \\>= 200mg\u002F24h\n   * serum free light chain difference \\>=10mg\u002FdL and abnormal FLC ratio\n8. Adequate organ function\n\n   * absolute neutrophil count \\>= 1.0 x 109\u002FL\n   * platelelt count \\>= 50 x 109\u002FL (plasmacytoma in the bone: \\>=30 x 109\u002FL)\n   * Hb \\>=8g\u002FdL\n   * serum creatinine \\\u003C 3.0mg\u002FdL or CCR \\>=15mL\u002Fmin\n   * serum AST and ALT \\\u003C=3 x ULN\n   * serum total bilirubin \\\u003C= 3 x ULN\n9. Subjects able to swallow oral drugs\n10. Subjects who had experienced toxicities to previous therapies: resolved from previous toxicities or stabilized of the toxicity to grade 1\n11. Subjects who had received allogenetic stem cell transplantation: no acitve graft-versus-host disease\n12. Subjects without clinically relevant bleeding\n13. Subjects who have informed consent to the study\n14. Females of childbearing potential (FCBP) must be negative to pregnancy testing and give consent to practice contraception before and during the treatment\n\nExclusion Criteria:\n\n1\\. Subjects who were previously exposed to carfilzomib\n\n1\\. Subjects who were previously exposed to cyclophosphamide 3. Subjects diagnosed with POEMS SD, Waldenstrom macroglobulinemia, Plasma cell leukemia 4. Subjects with concurrent heart conditions\n\n* Myocardial infarction within 6 months prior to treatment, New York Heart Association class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease,\n* Uncontrolled arrythmias (CVDAE version4 grade 2 or more) or symptomatic EKG abnormalities\n* 12-lead EKG : baseline ATcF \\> 470msec\n* 2D Echocardiography or MUGA scan : systolic EF \\\u003C 40% with clinically significant symptoms\n* Uncontrolled hypertension ( with medication: systolic BP \\>= 160 mmHg or diastolic BP \\>= 100 mmHg) 5. Chronc obstructive pulmonary disease (FEV1 \\\u003C 60%), history of asthma within 2 years 6. Surgery under general anesthesia withing 2 weeks 7. Subjects diagnosed with malignancies within 5 years (except for cured skin cancer, cervical cancer, intraepithelial gastrointestinal tract cancer after curative procedures or surgery for more than 3 years) 8. Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent 9. Pregnant or breatfeeding subjecs",{"count":54,"type":21},49,[56],"PHASE2","This study aims to study the efficacy and safety of oral cyclophosphamide in addition to carfilzomib and dexamethadone for RRMM patients who have been previously exposed to lenalidomide combination therapies.",[59,60],"Multiple Myeloma in Relapse","Multiple Myeloma, Refractory","2023-06-08",{"date":63,"type":36},"2023-06-18",{"date":65,"type":21},"2023-07-01",{"date":67,"type":21},"2027-06-30",{"name":42,"class":43},""]