Safety and Efficacy of the Bispecific T-Cell Engager (BiTE) as Conditioning Regimen for ABO-incompatible Living Donor Kidney Transplantation

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWest China Hospital

About this trial

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:

Can Bites effectively reduce blood group antibodies? What are the safety concerns that participants may have when using Bites?

Participants will:

Be 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.

The adverse drug reactions and the times of rescue were recorded.

Eligibility criteria

Qualifiers

Age ≥18 years old and ≤65 years old, regardless of gender

End-stage renal disease (ESRD) diagnosed clinically and pathologically, estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m², or undergoing maintenance dialysis (hemodialysis or peritoneal dialysis) for ≥3 months

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

Pre-existing anti-donor ABO blood group antibody titer (IgG+IgM) ≥1:16 (determined by standard tube method or microcolumn gel method)

Disqualifiers

patients allergic to the components of rituximab, teritumumab and berintuomab;

Hematologic diseases or myelosuppression (ANC < 1.0×10⁹/L, PLT < 75×10⁹/L);

multi-organ recipients, such as patients undergoing or having bone marrow transplantation or other organ transplantation at the same time;

acute active infection (including HBV, HCV, HIV, uncontrolled bacterial/fungal infection);

Trial design

Treatments tested in this trial

  • Blinatumomab Treatment
  • Teclistamab treat

Treatment groups

20 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators