NCT02107963View on ClinicalTrials.gov

A Phase I Trial of T Cells Expressing an Anti-GD2 Chimeric Antigen Receptor in Children and Young Adults With GD2+ Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

August 15, 2016

Study Completion Date

January 31, 2017

Conditions
SarcomaOsteosarcomaNeuroblastomaMelanoma
Interventions
BIOLOGICAL

Anti-GD2-CAR engineered T cells

Administer anti-GD2 CAR T cells 1 x 105 transduced T cells/kg; 1 x 106 transduced T cells/kg; 3 x 106 transduced T cells/kg; and 1 x 107 transduced T cells/kg

DRUG

AP1903

If unacceptable toxicity occurs that is possibly, probably or likely related to anti-GD2-CAR T cells, AP1903, a dimerizing agent, may be administered to mediate clearance of the genetically engineered cells and resolve toxicity

DRUG

Cyclophosphamide

1800mg/m2/d X 2 days as a lymphodepleting regimen

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT02107963 - A Phase I Trial of T Cells Expressing an Anti-GD2 Chimeric Antigen Receptor in Children and Young Adults With GD2+ Solid Tumors | Biotech Hunter | Biotech Hunter