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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: ABO Blood Type Incompatible Kidney Transplantation
• Intervention / Treatment: Drug: Teclistamab treat; Drug: Blinatumomab Treatment

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years old and ≤65 years old, regardless of gender
2. 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
3. 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
4. Pre-existing anti-donor ABO blood group antibody titer (IgG+IgM) ≥1:16 (determined by standard tube method or microcolumn gel method)
5. 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

Exclusion Criteria:

1. patients allergic to the components of rituximab, teritumumab and berintuomab;
2. Hematologic diseases or myelosuppression (ANC < 1.0×10⁹/L, PLT < 75×10⁹/L);
3. multi-organ recipients, such as patients undergoing or having bone marrow transplantation or other organ transplantation at the same time;
4. acute active infection (including HBV, HCV, HIV, uncontrolled bacterial/fungal infection);
5. Severe cardiac dysfunction (NYHA class III-IV)
6. known or suspected hereditary complement deficiency
7. 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).
8. Central nervous system diseases: epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis, visual impairment, cranial neuropathy requiring intervention, etc.
9. complicated with other uncontrolled malignant tumors;
10. women who are pregnant, breastfeeding or planning to become pregnant;
11. patients with poor compliance before and after surgery, or unable to cooperate with treatment and research due to other mental diseases;
12. Patients who were not eligible for the study for other reasons according to the investigator's judgment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Teclistamab Group	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
Experimental: Blinatumomab Group	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood group antibody titer	The blood group antibody titer (IgG+IgM) was reduced to ≤1:8-16 within a specified time window (repeated twice within 2 months) after the end of the drug administration, and this standard status was maintained until the day of surgery	Within 2 months after the end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Treatment	The incidence of drug-related adverse reactions (CRS, ICANS, infection, bone marrow suppression, hypogammaglobulinemia, infusion/injection reactions, catheter-related complications, etc.) during treatment and follow-up period	From treatment to the end of transplantation at 1 year

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: WestChina-BITE-ABOi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No