41
Participants
Start Date
January 13, 2016
Primary Completion Date
December 31, 2037
Study Completion Date
December 31, 2037
Cohort 1
"Subjects \<50kg will receive 0.2-1 x 10\^7 CART22 cells/kg as a split dose over three days as follows:~Day 1, 10% fraction: 0.2-1x10\^6 CART22 cells/kg Day 2, 30% fraction: 0.6-3x10\^6 CART22 cells/kg Day 3, 60% fraction: 1.2-6x10\^6 CART22 cells/kg~Subjects ≥50kg will receive 1-5x10\^8 CART22 cells as a split dose over three days as follows:~Day 1, 10% fraction: 1-5x10\^7 CART22 cells/kg Day 2, 30% fraction: 0.3-1.5x10\^8 CART22 cells/kg Day 3, 60% fraction: 0.6-3x10\^8 CART22 cells/kg"
Cohorts 2
"Subjects \<50kg will receive 0.2-1 x 10\^7 CART22-65s cells/kg as a split dose over three days as follows:~Day 1, 10% fraction: 0.2-1x10\^6 CART22-65s cells/kg Day 2, 30% fraction: 0.6-3x10\^6 CART22-65s cells/kg Day 3, 60% fraction: 1.2-6x10\^6 CART22-65s cells/kg~Subjects ≥50kg will receive 1-5x10\^8 CART22-65s cells as a split dose over three days as follows:~Day 1, 10% fraction: 1-5x10\^7 CART22-65s cells/kg Day 2, 30% fraction: 0.3-1.5x10\^8 CART22-65s cells/kg Day 3, 60% fraction: 0.6-3x10\^8 CART22-65s cells/kg"
Cohort 3
"Subjects \<50kg will receive 0.2-1 x 10\^7 CART22-65s cells as a split dose over two days as follows:~Day 1, 25% fraction: 0.5-2.5x10\^6 CAR T cells/kg Day 2, 75% fraction: 1.5-7.5x10\^6 CAR T cells/kg~Subjects ≥50kg will receive 1-5x10\^8 CART22-65s cells as a split dose over two days as follows:~Day 1, 25% fraction: 0.25-1.25x10\^8 CART22-65s cells Day 2, 75% fraction: 0.75-3.75x10\^8 CART22-65s cells"
RECRUITING
Children's Hospital of Philadelphia, Philadelphia
Children's Hospital of Philadelphia
OTHER
University of Pennsylvania
OTHER