30
Participants
Start Date
March 12, 2019
Primary Completion Date
March 22, 2027
Study Completion Date
March 22, 2043
iC9-CAR19 T cells
iC9-CAR19 T cells will be given by a licensed healthcare provider via intravenous injection over 5-10 minutes through either a peripheral or a central line.
Bendamustine
70mg/m2 IV given as a daily infusion for 3 days per institutional guidelines 2 - 14 days prior to the T cell infusion.
Fludarabine
30 mg/m2 given as a daily infusion for 3 days per institutional guidelines 2 - 14 days prior to the T cell infusion
AP1903
"0.4 mg/kg of AP1903 as an IV infusion over 2 hrs for subjects who develop Grade 4 cytokine release syndrome (CRS) or grade ≥3 CRS that is unresponsive to standard of care interventions , subjects who develop grade ≥3 Immune effector cell-associated neurotoxicity syndrome (ICANS) that does not improve to grade ≤1 within 72 hours with standard of care interventions, and subjects with grade 4 ICANS of any duration that have evidence of cerebral edema and/or generalized convulsive status epilepticus.~Subjects in the expansion cohort who experience ≥ grade 2 CRS or ICANS that remains ≥ grade 2, twenty-four hours after an initial dose of the standard of care treatment may be part of the sub-study of rimiducid. These subjects will receive one of two assigned dose levels. DL1 and DL2 doses are 0.05 mg/kg and 0.01 mg/kg for subjects and DL1: 0.1 mg/kg and DL2: 0.01 mg/kg for subjects with ICANS."
Cyclophosphamide
500 mg/m2/day administered by IV over 3 consecutive days
RECRUITING
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill
UNC Chapel Hill University Cancer Research Fund
UNKNOWN
The V Foundation
OTHER
M.D. Anderson Cancer Center
OTHER
UNC Lineberger Comprehensive Cancer Center
OTHER