T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

October 23, 2014

Primary Completion Date

October 23, 2025

Study Completion Date

October 23, 2025

Conditions
Advanced Non-Small Cell Lung CancerSquamous Cell CarcinomaAdvanced NSCLCAdenosquamous CarcinomaAdenocarcinoma
Interventions
DRUG

Aldesleukin

Aldesleukin 720,000 (Arm 1) or 72,000 (Arm 2) IU/kg IV (based on total body weight) over 15 minutes every 8 hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to a maximum of 9 doses in Arm 1 and 12 doses in Arm 2.

DRUG

Fludarabine

Days -7 to -3: Fludarabine 25 mg/m2/day 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 D5W with Mesna 15 mg/kg/day X 2 days over 1 hour.

BIOLOGICAL

Young TIL

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

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH