CLINICAL EVALUATION OF INDUCTION IMMUNOSUPPRESSION WITH A MURINE IGG(2B) MONOCLONAL-ANTIBODY (BMA-031) DIRECTED TOWARD THE HUMAN ALPHA BETA-T-CELL RECEPTOR/

Mouse mAbs directed against the (alpha/beta-TCR were tested in clinica l phase II and in triple-blind, randomized phase III studies. A clinic al phase II trial administered 50 mg of murine anti-human alpha/beta-T CR 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 advers e side effects. A phase III, triple-blind randomized trial enrolled 24 patients in the BMA 031 group and 22 patients in a placebo control gr oup. BMA 031 treatment significantly reduced the incidence of rejectio n events within the first 10 posttransplant days to I patient versus 9 episodes in the placebo group (P<0.01). By the end of 30 days, 6 reje ction 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 all ograft survival rate was 87% in the BMA-treated group compared with 68 % in the control cohort.