11
Participants
Start Date
October 31, 2015
Primary Completion Date
November 30, 2020
Study Completion Date
November 30, 2020
BL-8040
Subjects will receive subcutaneous (SC) injections of BL-8040 monotherapy on days 1-10 of the study. Beginning on Month 2 day 1, (M2/D1), and continuing monthly through Month 6, BL-8040 will be administered daily as part of the maintenance period for the first 5 days of each month.
horse anti-thymocyte globulin (hATG)
From Day 11 through Day 14 of first month, subjects will receive hATG infusion over 6-8 hours each day.
Methylprednisolone
From Day 11-14 of first month, subjects receive infusion of methylprednisolone 30 minutes prior to hATG infusion. Treatment with methylprednisolone will continue for 30 days. (After day 14, subjects may receive oral prednisone dose equivalent to IV methylprednisolone dose. The oral dose will be tapered off over 30 days.
Cyclosporine
From Day 11 through end of treatment (Month 6 Day 30), subjects will receive oral dose of cyclosporine.
MD Anderson Cancer Center, Houston
Lead Sponsor
BioLineRx, Ltd.
INDUSTRY