T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

October 24, 2013

Primary Completion Date

April 6, 2020

Study Completion Date

April 6, 2020

Conditions
MelanomaMeningiomaBreast CancerNon-Small Cell Lung CancerHepatocellular Cancer
Interventions
BIOLOGICAL

Anti-NY ESO-1 mTCR PBL

Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.

DRUG

Cyclophosphamide

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenously (IV) in 250 mL dextrose 5% in water (D5W) infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.

DRUG

Fludarabine

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

DRUG

Aldesleukin

Aldesleukin 720,000 IU/kg intravenously (IV) (based on total body weight) over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).

Trial Locations (1)

20892

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

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT01967823 - T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Cancer | Biotech Hunter | Biotech Hunter