3rd Generation GD-2 Chimeric Antigen Receptor and ICaspase Suicide Safety Switch, Neuroblastoma, GRAIN

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

December 31, 2015

Study Completion Date

October 31, 2030

Conditions
Neuroblastoma
Interventions
GENETIC

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."

GENETIC

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."

DRUG

Cytoxan

Cyclophosphamide (500 mg/m2/day x 2 days, for patients \<12 kg = 16.7 mg/kg/day x 2 days)

DRUG

Fludara

Fludarabine (30 mg/m2/day x 3 days, for patients \<12 kg = 1 mg/kg/day x 3 days)

DRUG

Keytruda

Pembrolizumab (2 mg/kg on Day -1 and on Day 21).

GENETIC

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."

Trial Locations (2)

77030

Houston Methodist Hospital, Houston

Texas Children's Hospital, Houston

Sponsors
All Listed Sponsors
collaborator

Center for Cell and Gene Therapy, Baylor College of Medicine

OTHER

collaborator

The Methodist Hospital Research Institute

OTHER

collaborator

Solving Kids' Cancer

OTHER

collaborator

The Evan Foundation

OTHER

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Kids Cancer Research Foundation

OTHER

lead

Baylor College of Medicine

OTHER