Clinical evaluation of induction immunosuppression with a murine IgG<inf>2b</inf>monoclonal antibody (BMA 031) directed toward the human α/β-T cell receptor Academic Article uri icon

Overview

MeSH Major

  • Antibodies, Monoclonal
  • Immunoglobulin G
  • Immunosuppressive Agents
  • Kidney Transplantation
  • Receptors, Antigen, T-Cell, alpha-beta

abstract

  • Mouse mAbs directed against the alpha/beta-TCR were tested in clinical phase II and in triple-blind, randomized phase III studies. A clinical phase II trial administered 50 mg of murine anti-human alpha/beta-TCR mAb (BMA 031) intravenously on the day of, as well as 2 and 4 days after, cadaveric donor renal transplantation in combination with a CsA/prednisone regimen. None of 12 patients showed even moderately adverse side effects. A phase III, triple-blind randomized trial enrolled 24 patients in the BMA 031 group and 22 patients in a placebo control group. BMA 031 treatment significantly reduced the incidence of rejection events within the first 10 posttransplant days to 1 patient versus 9 episodes in the placebo group (P < 0.01). By the end of 30 days, 6 rejection episodes had occurred in the BMA 031 group and 11 in the control cohort (P = NS). After a minimum of 30 months follow-up, the actual allograft survival rate was 87% in the BMA-treated group compared with 68% in the control cohort.

publication date

  • January 1994

Research

keywords

  • Academic Article

Identity

Language

  • eng

PubMed ID

  • 8009591

Additional Document Info

start page

  • 1581

end page

  • 8

volume

  • 57

number

  • 11