A Study of Metastatic Gastrointestinal Cancers Treated With Tumor Infiltrating Lymphocytes in Which the Gene Encoding the Intracellular Immune Checkpoint CISH Is Inhibited Using CRISPR Genetic Engineering

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 15, 2020

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Gastrointestinal Epithelial CancerGastrointestinal NeoplasmsCancer of Gastrointestinal TractCancer, GastrointestinalGastrointestinal CancerColo-rectal CancerPancreatic CancerGall Bladder CancerColon CancerEsophageal CancerStomach Cancer
Interventions
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.

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.

BIOLOGICAL

Tumor-Infiltrating Lymphocytes (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.

Trial Locations (1)

55455

Masonic Cancer Center, University of Minnesota, Minneapolis

Sponsors
All Listed Sponsors
collaborator

Masonic Cancer Center, University of Minnesota

OTHER

lead

Intima Bioscience, Inc.

INDUSTRY