T Cell Receptor Immunotherapy Targeting HPV-16 E6 for HPV-Associated Cancers

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

October 14, 2014

Primary Completion Date

June 28, 2016

Study Completion Date

June 28, 2016

Conditions
Vaginal CancerCervical CancerAnal CancerPenile CancerOropharyngeal Cancer
Interventions
DRUG

Fludarabine

Patients will receive Fludarabine 25 mg/m\^2/day for 5 days.

DRUG

Cyclophosphamide

Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days

BIOLOGICAL

E6 TCR

On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)

DRUG

Aldesleukin

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

NCT02280811 - T Cell Receptor Immunotherapy Targeting HPV-16 E6 for HPV-Associated Cancers | Biotech Hunter | Biotech Hunter