[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hla-sensitization\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hla-sensitization":27},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100646533","phase-4-safety-and-efficacy-of-bite-in-desensitization-therapy-for-highly-sensitized-kidney-transplant-candidates-with-cpra--90-100646533",false,"NCT07689149","Safety and Efficacy of BiTE in Desensitization Therapy for Highly Sensitized Kidney Transplant Candidates With cPRA ≥ 90%","Inclusion Criteria:\n\n* Male or female participants aged 18 to 65 years.\n* Diagnosis of end-stage kidney disease and being evaluated for or awaiting kidney transplantation.\n* Calculated panel-reactive antibody level (cPRA) ≥90% and a kidney transplant waiting time of ≥5 years.\n* Previous treatment with a conventional desensitization regimen based on intravenous immunoglobulin and\u002For plasma exchange, with or without rituximab, with traceable medical records.\n* Persistent cPRA ≥90% or unacceptable HLA antibodies after conventional desensitization, resulting in failure to meet the immunological criteria for kidney transplantation.\n* Adequate nonrenal organ function to tolerate the study treatment, including left ventricular ejection fraction \\>50%, resting oxygen saturation \\>94%, AST and ALT \\\u003C3 times the upper limit of normal, total bilirubin \\\u003C34.2 μmol\u002FL, and no active infection.\n* Ability to understand the study procedures, provide written informed consent, and comply with study treatment and follow-up requirements.\n\nExclusion Criteria:\n\n* Inability to understand or comply with the study protocol or follow-up schedule.\n* Known or suspected hereditary complement deficiency.\n* Clinically significant central nervous system disease, including epilepsy, psychotic disorder, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis, or cranial neuropathy requiring intervention.\n* AST, ALT, or GGT \\>3 times the upper limit of normal, or alkaline phosphatase or total bilirubin \\>1.5 times the upper limit of normal.\n* Acute myocardial infarction or unstable angina within 6 months before screening, severe cardiac arrhythmia, or New York Heart Association class III or IV heart failure.\n* Uncontrolled acute or chronic disease unrelated to end-stage kidney disease that may impair tolerance to study treatment.\n* Active or uncontrolled infection requiring systemic treatment.\n* Human immunodeficiency virus infection or uncontrolled active hepatitis B or hepatitis C infection.\n* Participation in another interventional clinical study within 3 months before screening or planned concurrent participation in another interventional study.\n* Previous treatment with another T-cell engager or bispecific T-cell-redirecting therapy.\n* Known severe hypersensitivity to blinatumomab, teclistamab, or any of their excipients.\n* Active malignancy.\n* Pregnancy, breastfeeding, or planned pregnancy during the study period.\n* Previous bone marrow transplantation, hematopoietic stem cell transplantation, or solid-organ transplantation other than kidney transplantation.\n* Receipt of a live vaccine within 30 days before screening or planned receipt of a live vaccine during study treatment.\n* Any other clinically significant condition that, in the investigator's judgment, may increase participant risk, interfere with study procedures, or affect safety or efficacy assessments.","ALL","18 Years","65 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This study is a prospective, open-label, two-arm exploratory clinical trial aimed at evaluating the safety and efficacy of Bispecific T-cell Engager (BiTE) therapies in refractory, highly sensitized kidney transplant candidates. Patients with end-stage renal disease (ESRD) who have a calculated panel reactive antibody (cPRA) ≥ 90% and have waited for a transplant for over 5 years, despite receiving standard desensitization therapies (e.g., IVIG, plasmapheresis, rituximab), will be enrolled.\n\nA total of 20 participants will be randomized in a 1:1 ratio to receive either Blinatumomab (a CD19×CD3 BiTE) or Teclistamab (a BCMA×CD3 BiTE). The primary objective is to evaluate the desensitization response rate, defined as the reduction of cPRA to \\\u003C 20% or by ≥ 50% from baseline, assessed at multiple time points up to 1 year post-treatment. Secondary objectives include assessing the safety profile (such as the incidence of Cytokine Release Syndrome \\[CRS\\] and neurotoxicity), the extent of CD19+ B cell depletion, and the proportion of participants who successfully undergo kidney transplantation within 1 year.",[26,27],"Kidney Transplantation Recipients","HLA Sensitization",[29,30,31,32],"Bispecific T-cell Engager","Desensitization","Kidney Transplantation","HLA Antibodies","NOT_YET_RECRUITING","2026-07-04",{"date":36,"type":37},"2026-07-08","ACTUAL",{"date":39,"type":20},"2026-06-30",{"date":41,"type":20},"2029-12-31",{"name":43,"class":44},"West China Hospital","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100640982","phase-1-immunological-reset-to-enable-access-to-hla-compatible-kidney-transplantation-in-highly-sensitized-patients-reset-100640982","NCT07607197","Immunological Reset to Enable Access to Hla-compatible Kidney Transplantation in Highly Sensitized Patients (RESET)","Immune Reset to Allow Access to Hla-compatible Kidney Transplantation in Hyperimmunized Patients","HIPER-RESET","Inclusion Criteria:\n\n* Patients aged between 18 and 60 years.\n* Diagnosis of end-stage kidney disease (ESRD) currently maintained on chronic dialysis.\n* Highly sensitized\u002Fhyperimmunized status, defined by a high calculated Panel Reactive Antibody (cPRA) level (e.g., \\>= 95%).\n* Active status on the deceased-donor kidney transplant waiting list.\n* Adequate bone marrow, hepatic, cardiac, and pulmonary function to safely undergo the conditioning regimen and AHSCT.\n* Capable of understanding the study requirements and providing written informed consent.\n\nExclusion Criteria:\n\n* Contraindications to the conditioning regimen medications (rituximab, cyclophosphamide, or rATG).\n* Active, uncontrolled systemic infection, or chronic active infection (including HIV, active Hepatitis B or C, or active tuberculosis).\n* Significant cardiac dysfunction (e.g., Left Ventricular Ejection Fraction \\\u003C 50%) or severe underlying pulmonary disease.\n* History of malignant neoplasm within the past 5 years, excluding successfully treated non-melanoma skin cancer or carcinoma in situ.\n* Previous autologous or allogeneic hematopoietic stem cell transplantation.\n* Pregnancy or breastfeeding.\n* Any psychiatric, medical, or geographical condition that, in the investigator's opinion, prevents compliance with the protocol and long-term follow-up.","60 Years",{"count":55,"type":20},10,[57,58],"PHASE1","PHASE2","The purpose of this clinical trial is to evaluate whether a temporary reprogramming of the immune system can help highly sensitized (hyperimmunized) patients with end-stage kidney disease safely receive a compatible kidney transplant.\n\nPatients who are highly sensitized have developed an extremely high level of antibodies against human leukocyte antigens (HLA), often due to previous transplants, pregnancies, or blood transfusions. This condition makes it nearly impossible for them to find a compatible organ donor, leaving them stuck on dialysis indefinitely.\n\nThis study tests an innovative strategy using Autologous Hematopoietic Stem Cell Transplantation (AHSCT). The procedure involves an intensive conditioning regimen using a combination of medications (cyclophosphamide, thymoglobulin, and rituximab) to deeply clear out the patient's existing mature immune cells. This is followed by the reinfusion of the patient's own previously collected and purified blood stem cells (CD34+ cells) to rebuild the immune system from scratch.\n\nThe investigators hypothesize that this procedure will eliminate the \"immunological memory\" cells responsible for producing the problematic anti-HLA antibodies, resetting the immune system to a \"naive\" or inactive state. This immune reset is expected to eliminate or significantly lower circulating HLA antibodies, creating a critical window of opportunity for these patients to successfully receive a compatible kidney transplant from the deceased-donor waiting list.",[61,31,62,27,63,64],"Kidney Failure, Chronic","Alloimmunization","End Stage Cronic Kidney Disease","Highly Sensitized Patients Awaiting Kidney Transplant",[66,67,31,68,69,30,70,71,72,73,74],"Autologous Hematopoietic Stem Cell Transplantation","AHSCT","Highly sensitized","Hyperimmunized","Anti-HLA Antibodies","CD34+ Cells","Transplant Immunology","End-Stage Kidney Disease","Immune Reset","RECRUITING","2026-06-02",{"date":78,"type":37},"2026-06-04",{"date":80,"type":37},"2024-02-01",{"date":82,"type":20},"2028-06",{"name":84,"class":44},"Hospital Universitari Vall d'Hebron Research Institute",1]