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NCT07689149

PHASE4

Safety and Efficacy of BiTE in Desensitization Therapy for Highly Sensitized Kidney Transplant Candidates With cPRA ≥ 90%

Sponsor: West China Hospital

View on ClinicalTrials.gov

Summary

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. A 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 \< 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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-06-30

Completion Date

2029-12-31

Last Updated

2026-07-08

Healthy Volunteers

Conditions

Kidney Transplantation Recipients HLA Sensitization

Interventions

DRUG

BiTE (CD19 x CD3 Bispecific Antibody)

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/day 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/day for 4 consecutive days.

DRUG

BiTE (BCMA x CD3 Bispecific Antibody)

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/kg on Day 1, followed by 0.3 mg/kg on Day 2. After the 7-day interval, Cycle 2 (Days 10-11) is initiated, during which a target dose of 1.5 mg/kg is administered on Day 10.

Inclusion Criteria: * Male or female participants aged 18 to 65 years. * Diagnosis of end-stage kidney disease and being evaluated for or awaiting kidney transplantation. * Calculated panel-reactive antibody level (cPRA) ≥90% and a kidney transplant waiting time of ≥5 years. * Previous treatment with a conventional desensitization regimen based on intravenous immunoglobulin and/or plasma exchange, with or without rituximab, with traceable medical records. * Persistent cPRA ≥90% or unacceptable HLA antibodies after conventional desensitization, resulting in failure to meet the immunological criteria for kidney transplantation. * Adequate nonrenal organ function to tolerate the study treatment, including left ventricular ejection fraction \>50%, resting oxygen saturation \>94%, AST and ALT \<3 times the upper limit of normal, total bilirubin \<34.2 μmol/L, and no active infection. * Ability to understand the study procedures, provide written informed consent, and comply with study treatment and follow-up requirements. Exclusion Criteria: * Inability to understand or comply with the study protocol or follow-up schedule. * Known or suspected hereditary complement deficiency. * 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. * 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. * 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. * Uncontrolled acute or chronic disease unrelated to end-stage kidney disease that may impair tolerance to study treatment. * Active or uncontrolled infection requiring systemic treatment. * Human immunodeficiency virus infection or uncontrolled active hepatitis B or hepatitis C infection. * Participation in another interventional clinical study within 3 months before screening or planned concurrent participation in another interventional study. * Previous treatment with another T-cell engager or bispecific T-cell-redirecting therapy. * Known severe hypersensitivity to blinatumomab, teclistamab, or any of their excipients. * Active malignancy. * Pregnancy, breastfeeding, or planned pregnancy during the study period. * Previous bone marrow transplantation, hematopoietic stem cell transplantation, or solid-organ transplantation other than kidney transplantation. * Receipt of a live vaccine within 30 days before screening or planned receipt of a live vaccine during study treatment. * 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.

Clinical Research Directory

Safety and Efficacy of BiTE in Desensitization Therapy for Highly Sensitized Kidney Transplant Candidates With cPRA ≥ 90%

Summary

Key Details

Conditions

Interventions

Eligibility Criteria