11
Participants
Start Date
August 31, 2013
Primary Completion Date
December 31, 2015
Study Completion Date
October 31, 2030
iC9-GD2 T Cells - frozen
"Subjects will receive the iC9-GD2 T cells through an IV over 5 to 10 minutes.~Subjects will receive one of the following dose levels (cells/m2):~* Dose Level 1 = 1 x 10\^7~* Dose Level 2 = 1 x 10\^8~* Dose Level 3 = 2 x 10\^8~Six weeks after the infusion, patients will have a disease re-evaluation. If the disease has not gotten worse AND they have not had a severe side effect caused by the infusion of the iC9-GD2 T cells, the subject may be eligible to receive up to 2 additional doses of T cells. Each dose will be at the same dose level as the first infusion, if available, and separated by at least 6 weeks."
iC9-GD2 T Cells - fresh
"For subjects who will receive a fresh T cell product:~* Dose Level 1 = 1 x 10\^8~* Dose Level 2 = 1.5 x 10\^8~* Dose Level 3 = 2 x 10\^8~Six weeks after the infusion, patients will have a disease re-evaluation. If the disease has not gotten worse AND they have not had a severe side effect caused by the infusion of the iC9-GD2 T cells, the subject may be eligible to receive up to 2 additional doses of T cells. Each dose will be at the same dose level as the first infusion, if available, and separated by at least 6 weeks."
Cytoxan
Cyclophosphamide (500 mg/m2/day x 2 days, for patients \<12 kg = 16.7 mg/kg/day x 2 days)
Fludara
Fludarabine (30 mg/m2/day x 3 days, for patients \<12 kg = 1 mg/kg/day x 3 days)
Keytruda
Pembrolizumab (2 mg/kg on Day -1 and on Day 21).
iC9-GD2 T cells
"For subjects who will receive a fresh T cell product:~* Dose Level 1 = 1.5 x 10\^8~* Dose Level 2 = 2 x 10\^8~Six weeks after the infusion, patients will have a disease re-evaluation. If the disease has not gotten worse AND they have not had a severe side effect caused by the infusion of the iC9-GD2 T cells, the subject may be eligible to receive up to 2 additional doses of T cells. Each dose will be at the same dose level as the first infusion, if available, and separated by at least 6 weeks."
Houston Methodist Hospital, Houston
Texas Children's Hospital, Houston
Collaborators (1)
Center for Cell and Gene Therapy, Baylor College of Medicine
OTHER
The Methodist Hospital Research Institute
OTHER
Solving Kids' Cancer
OTHER
The Evan Foundation
OTHER
National Cancer Institute (NCI)
NIH
Kids Cancer Research Foundation
OTHER
Baylor College of Medicine
OTHER