CISH Inactivated TILs in the Treatment of NSCLC

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

February 28, 2023

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2027

Conditions
Carcinoma, Non-Small-Cell LungMetastatic Non Small Cell Lung CancerStage IV Non-small Cell Lung CancerSquamous Cell Lung CancerAdenocarcinoma of LungLarge Cell Lung Cancer
Interventions
DRUG

Fludarabine

Day -7 to Day -3 : Fludarabine 25 mg/m\^2/dose as a 1 hour intravenous infusion per institutional guidelines once a day for 5 doses beginning on Day -7. Fludarabine will be started approximately 1 to 2 hours after the cyclophosphamide on Day -6 and Day -5.

DRUG

Cyclophosphamide

Day -6 and Day -5: Cyclophosphamide 60 mg/kg/dose as a 2 hour intravenous infusion with Mesna 15 mg/kg/dose, 1st dose prior to Cyclophosphamide infusion then at 3,6,9 and 12 hours later.

BIOLOGICAL

CISH Inactivated TIL

Day 0 : Each bag of autologous CISH inactivated TIL for infusion will be administered intravenously (IV) on the Patient Care Unit over 10-20 minutes at assigned dose level.

DRUG

Aldesleukin

Days 1-4 : Aldesleukin at 720,000 U/kg as an intravenous infusion, every 8 -12 hours but, no more than 24 hours apart as tolerated for up to 6 doses.

DRUG

Pembrolizumab

Administered as maintenance therapy in some patients starting at first follow-up (400 mg/dose starting Day 28 /Week 4 then every 6 weeks thereafter until disease progression, unacceptable toxicity, or up to 24 months)

Trial Locations (2)

55455

Masonic Cancer Center, University of Minnesota, Minneapolis

91010

City of Hope Comprehensive Cancer Center, Duarte

Sponsors
All Listed Sponsors
lead

Intima Bioscience, Inc.

INDUSTRY

NCT05566223 - CISH Inactivated TILs in the Treatment of NSCLC | Biotech Hunter | Biotech Hunter