[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646533":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":24,"responsibleParty":34,"collaborators":24,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":24,"eligibilityCriteria":43,"healthyVolunteers":40,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":24,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":62,"whyStopped":24,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":24},{"fullName":5,"class":6},"West China Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bispecific T cell engager treatment group1：Blinatumomab group","EXPERIMENTAL","BiTE (CD19 x CD3 Bispecific Antibody)",[13],"Drug: BiTE (CD19 x CD3 Bispecific Antibody)",{"label":15,"type":10,"description":16,"interventionNames":17},"Bispecific T cell engager treatment group2：Teclistamab group","BiTE (BCMA x CD3 Bispecific Antibody)",[18],"Drug: BiTE (BCMA x CD3 Bispecific Antibody)",[20,25],{"type":21,"name":11,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Blinatumomab is a CD19×CD3 bispecific T-cell engager (BiTE) administered via intravenous infusion. This intervention utilizes a specific low-dose, short-course exploratory regimen tailored for non-oncology kidney transplant candidates to safely deplete B cells and reduce HLA antibodies. The treatment consists of two cycles separated by a 7-day interval. In Cycle 1 (Days 1-4), patients receive a continuous infusion of 9 µg\u002Fday for 4 consecutive days, with a total target dose of 35 µg for the cycle. Following the 7-day interval, Cycle 2 (Days 12-15) is administered with the identical regimen of 9 µg\u002Fday for 4 consecutive days.",[9],null,{"type":21,"name":16,"description":26,"armGroupLabels":27,"otherNames":24},"Teclistamab is a BCMA×CD3 bispecific T-cell engager (BiTE) administered via subcutaneous injection. To mitigate the early risk of cytokine release syndrome (CRS), this intervention employs a strictly defined step-up dosing schedule. The treatment involves two cycles separated by a 7-day interval. Cycle 1 (Days 1-2) begins with a step-up dose of 0.06 mg\u002Fkg on Day 1, followed by 0.3 mg\u002Fkg on Day 2. After the 7-day interval, Cycle 2 (Days 10-11) is initiated, during which a target dose of 1.5 mg\u002Fkg is administered on Day 10.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Chenliang Xu, Master of Clinical Medicine","CONTACT","+86 17208274528","fancyplain@163.com",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Turun Song","Associate Chief Physician","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":48,"type":49},20,"ESTIMATED","INTERVENTIONAL",[52],"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.",[55,56],"Kidney Transplantation Recipients","HLA Sensitization",[58,59,60,61],"Bispecific T-cell Engager","Desensitization","Kidney Transplantation","HLA Antibodies","NOT_YET_RECRUITING","2026-07-04",{"date":65,"type":66},"2026-07-08","ACTUAL",{"date":68,"type":49},"2026-06-30",{"date":70,"type":49},"2029-12-31",{"name":5,"class":6}]