17
Participants
Start Date
March 22, 2012
Primary Completion Date
December 12, 2025
Study Completion Date
August 12, 2040
iC9-CAR19 cells
Three dose levels are being evaluated: dose level -1 (1 x 10\^5), dose level 1 (5 x 10\^5), and dose level 2 ( 1x 10\^6)
Rimiducid
Subjects with CRS and ICAN will assign one of two dose levels (DL)s of rimiducid with the standard treatment: 0.05 mg/kg or 0.1 mg/kg for subjects with CRS and 0.01mg/kg or 0.1mg/kg for subjects with ICAN. Subjects will first be enrolled on DL 1 and then enrolled on DL 2, and 0.4mg/kg rimiducid will be given to subjects who did not respond to the initial dose.
Cyclophosphamide
900 mg/m\^2 IV over 1 hour on day 4 of lymphodepleting chemotherapy.
Fludarabine
25 mg/m\^2/day IV over 30 minutes administered for 3 consecutive days.
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill
Collaborators (1)
Bellicum Pharmaceuticals
INDUSTRY
The Leukemia and Lymphoma Society
OTHER
UNC Lineberger Comprehensive Cancer Center
OTHER