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

9. juli 2026 oppdatert av: Turun Song, West China Hospital

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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Tidlig fase 1

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Teclistamab Group
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
Eksperimentell: Blinatumomab Group
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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Blood group antibody titer
Tidsramme: Within 2 months after the end of treatment
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Safety of Treatment
Tidsramme: From treatment to the end of transplantation at 1 year
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

31. desember 2027

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

9. juli 2026

Først innsendt som oppfylte QC-kriteriene

9. juli 2026

Først lagt ut (Faktiske)

15. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • WestChina-BITE-ABOi

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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