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NOT YET RECRUITING
NCT07706205
EARLY_PHASE1

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

Sponsor: West China Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-09-01

Completion Date

2028-12-31

Last Updated

2026-07-15

Healthy Volunteers

No

Interventions

DRUG

Blinatumomab Treatment

Blinatumomab: Cycle 1 (Day 0-Day 6) : 9ug/Day for 5 consecutive days, total dose 38.5ug; Cycle 2 was performed after a 9-day hospital interval; Cycle 2 (Day7-Day13) was 9ug/day on the first day for 5 consecutive days, and the total treatment dose was 38.5ug

DRUG

Teclistamab treat

Cycle 1 (Day 1-day 9) Day1 0.06mg/kg, Day2 0.3mg/kg; Cycle 2 was performed after a 7-day interval. Cycle 2 (Day 10-Day 13) Day10 1.5mg/kg