[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647193":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":28,"collaborators":11,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":36,"acronym":11,"eligibilityCriteria":37,"healthyVolunteers":34,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":11,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":11,"overallStatus":50,"whyStopped":11,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":11},{"fullName":5,"class":6},"West China Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Teclistamab Group","EXPERIMENTAL",null,[13],"Drug: Teclistamab treat",{"label":15,"type":10,"description":11,"interventionNames":16},"Blinatumomab Group",[17],"Drug: Blinatumomab Treatment",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Blinatumomab Treatment","Blinatumomab: Cycle 1 (Day 0-Day 6) : 9ug\u002FDay for 5 consecutive days, total dose 38.5ug; Cycle 2 was performed after a 9-day hospital interval; Cycle 2 (Day7-Day13) was 9ug\u002Fday on the first day for 5 consecutive days, and the total treatment dose was 38.5ug",[15],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Teclistamab treat","Cycle 1 (Day 1-day 9) Day1 0.06mg\u002Fkg, Day2 0.3mg\u002Fkg; Cycle 2 was performed after a 7-day interval. Cycle 2 (Day 10-Day 13) Day10 1.5mg\u002Fkg",[9],{"type":29,"investigatorFullName":30,"investigatorTitle":31,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Turun Song","Associate Professor","100647193","early-phase-1-safety-and-efficacy-of-the-bispecific-t-cell-engager-bite-as-conditioning-regimen-for-abo-incompatible-living-donor-kidney-transplantation-100647193",false,"NCT07706205","Safety and Efficacy of the Bispecific T-Cell Engager (BiTE) as Conditioning Regimen for ABO-incompatible Living Donor Kidney Transplantation","Inclusion Criteria:\n\n1. Age ≥18 years old and ≤65 years old, regardless of gender\n2. End-stage renal disease (ESRD) diagnosed clinically and pathologically, estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73m², or undergoing maintenance dialysis (hemodialysis or peritoneal dialysis) for ≥3 months\n3. Plan to receive ABO-incompatible living donor kidney transplantation (ABOi-LDKT), and the matching has been approved by the organ transplantation ethics committee and technical committee of the hospital\n4. Pre-existing anti-donor ABO blood group antibody titer (IgG+IgM) ≥1:16 (determined by standard tube method or microcolumn gel method)\n5. able to understand study procedures, provide written informed consent, and be willing and able to comply with the study visit schedule and laboratory examination requirements\n\nExclusion Criteria:\n\n1. patients allergic to the components of rituximab, teritumumab and berintuomab;\n2. Hematologic diseases or myelosuppression (ANC \\\u003C 1.0×10⁹\u002FL, PLT \\\u003C 75×10⁹\u002FL);\n3. multi-organ recipients, such as patients undergoing or having bone marrow transplantation or other organ transplantation at the same time;\n4. acute active infection (including HBV, HCV, HIV, uncontrolled bacterial\u002Ffungal infection);\n5. Severe cardiac dysfunction (NYHA class III-IV)\n6. known or suspected hereditary complement deficiency\n7. abnormal liver function: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or glutamyl transpeptidase (GGT) \\> 3 times the upper limit of normal (ULN); Or alkaline phosphatase (ALP) or total bilirubin values greater than 1.5 times the upper limit of normal (ULN).\n8. Central nervous system diseases: epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis, visual impairment, cranial neuropathy requiring intervention, etc.\n9. complicated with other uncontrolled malignant tumors;\n10. women who are pregnant, breastfeeding or planning to become pregnant;\n11. patients with poor compliance before and after surgery, or unable to cooperate with treatment and research due to other mental diseases;\n12. Patients who were not eligible for the study for other reasons according to the investigator's judgment.","ALL","18 Years","65 Years",{"count":42,"type":43},20,"ESTIMATED","INTERVENTIONAL",[46],"EARLY_PHASE1","The goal of this clinical trial was to determine whether the Bites drugs (Blinatumomab and Teclistamab) can reduce blood group antibodies in recipients of living donor blood-incompatible kidney transplants for pretransplant conditioning. It will also understand the safety of Bites drugs in the transplant population. The main questions it aims to answer include:\n\nCan Bites effectively reduce blood group antibodies? What are the safety concerns that participants may have when using Bites?\n\nParticipants will:\n\nBe given Blinatumomab and Teclistamab at the standard dose prescribed by the manufacturer before surgery, and blood group antibodies were rechecked every two weeks to two months.\n\nThe adverse drug reactions and the times of rescue were recorded.",[49],"ABO Blood Type Incompatible Kidney Transplantation","NOT_YET_RECRUITING","2026-07-09",{"date":53,"type":54},"2026-07-15","ACTUAL",{"date":56,"type":43},"2026-09-01",{"date":58,"type":43},"2028-12-31",{"name":5,"class":6}]