CAR T Cell Receptor Immunotherapy Targeting EGFRvIII for Patients With Malignant Gliomas Expressing EGFRvIII

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

May 16, 2012

Primary Completion Date

November 1, 2018

Study Completion Date

January 17, 2019

Conditions
Malignant GliomaGlioblastomaBrain CancerGliosarcoma
Interventions
BIOLOGICAL

Epidermal growth factor receptor(EGFRv)III Chimeric antigen receptor (CAR) transduced PBL

Day 0: Cells will be infused intravenously over 20-30 minutes. Patients will receive two cell doses, 2 hours apart.

DRUG

Aldesleukin

Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).

DRUG

Fludarabine

Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.

DRUG

Cyclophosphamide

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT01454596 - CAR T Cell Receptor Immunotherapy Targeting EGFRvIII for Patients With Malignant Gliomas Expressing EGFRvIII | Biotech Hunter | Biotech Hunter