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

NCT07706205 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: WestChina-BITE-ABOi
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

ABO Blood Type Incompatible Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety of Treatment

  From treatment to the end of transplantation at 1 year

Study Arms (2)

Teclistamab Group

EXPERIMENTAL

Drug: Teclistamab treat

Blinatumomab Group

EXPERIMENTAL

Drug: Blinatumomab Treatment

Interventions

Blinatumomab Treatment DRUG

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

Blinatumomab Group

Teclistamab treat DRUG

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

Teclistamab Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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);
• Severe cardiac dysfunction (NYHA class III-IV)
• known or suspected hereditary complement deficiency
• 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).
• Central nervous system diseases: epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis, visual impairment, cranial neuropathy requiring intervention, etc.
• complicated with other uncontrolled malignant tumors;
• women who are pregnant, breastfeeding or planning to become pregnant;
• patients with poor compliance before and after surgery, or unable to cooperate with treatment and research due to other mental diseases;
• Patients who were not eligible for the study for other reasons according to the investigator's judgment.

Sponsors & Collaborators

• West China Hospital: lead

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 15, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share