C7R-GD2.CART Cells for Patients With Relapsed or Refractory Neuroblastoma and Other GD2 Positive Cancers (GAIL-N)

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

April 23, 2019

Primary Completion Date

May 16, 2023

Study Completion Date

May 16, 2038

Conditions
Relapsed NeuroblastomaRefractory NeuroblastomaRelapsed OsteosarcomaRelapsed Ewing SarcomaRelapsed RhabdomyosarcomaUveal MelanomaPhyllodes Breast Tumor
Interventions
GENETIC

C7R-GD2.CART cells

"Active dose levels:~C7R-GD2.CART cell without lymphodepletion (Arm A or Arm B)~Dose Level 2b = 3 x 10\^7 on day 0 and day 7~Dose Level 3b = 1 x 10\^8 on day 0 and day 7.~Day 7 dose (+- 2 days) will be omitted if patients have persistent CRS (Grade 2 or higher) experienced a DLT or for other clinical concerns at the discretion of the PI."

Trial Locations (2)

77030

Houston Methodist Hospital, Houston

Texas Children's Hospital, Houston

All Listed Sponsors
collaborator

Center for Cell and Gene Therapy, Baylor College of Medicine

OTHER

collaborator

The Methodist Hospital Research Institute

OTHER

collaborator

Cancer Prevention Research Institute of Texas

OTHER

lead

Baylor College of Medicine

OTHER