GD2 Specific CAR and Interleukin-15 Expressing Autologous NKT Cells to Treat Children With Neuroblastoma

PHASE1RecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

January 18, 2018

Primary Completion Date

December 31, 2027

Study Completion Date

August 10, 2040

Conditions
Neuroblastoma
Interventions
GENETIC

GINAKIT Cells

"Six dose levels of GINAKIT cells will be studied. Dosing will be based on the actual number of transduced cells. All doses are per m2.~* Dose Level 1 = 3 x 10\^6~* Dose Level 2 = 1 x 10\^7~* Dose Level 3 = 3 x 10\^7~* Dose Level 4 = 1 x 10\^8~* Dose Level 5 = 3 x 10\^8~* Dose Level 6 = 1 x 10\^9"

BIOLOGICAL

GINAKIT cells + Etanercept

"Four dose levels of GINAKIT cells in combination of Etanercept will be studied. Dosing will be based on the actual number of transduced cells. All doses are per m2.~* Combination Dose level 1: 3 x 10\^6 + Etanercept\*~* Combination Dose level 2: 1 x 10\^7 + Etanercept\*~* Combination Dose level 3: 3 x 10\^7 + Etanercept\*~* Combination Dose level 4: 1 x 10\^8 + Etanercept"

Trial Locations (1)

77030

RECRUITING

Texas Children's Hospital, Houston

All Listed Sponsors
collaborator

Center for Cell and Gene Therapy, Baylor College of Medicine

OTHER

lead

Baylor College of Medicine

OTHER