- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07706205
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Prima fase 1
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Blood group antibody titer
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Safety of Treatment
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- WestChina-BITE-ABOi
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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