MedTrace Logo

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

NCT07689149 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-07-08

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07689149 on ClinicalTrials.gov