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Clinical Trial Summary

This is a single center Phase I/II study to determine the safety of the administration of mutation reactive autologous lymphocytes with knockout of the CISH gene in adults with metastatic gastrointestinal epithelial cancer that have failed prior therapy. Up to 5 dose levels of cytokine-induced SH2 protein (CISH) inactivated tumor infiltrating lymphocytes (TILs) will be tested during a Phase I dose escalation plan followed by a Phase II Simon two-stage design portion.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Gastrointestinal Epithelial Cancer

NCT number NCT04089891
Study type Interventional
Source Masonic Cancer Center, University of Minnesota
Contact Emil Lou, MD, PhD, FACP
Phone 612-624-5944
Email emil-lou@umn.edu
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date October 2019
Completion date October 2024

See also
  Status Clinical Trial Phase
Withdrawn NCT03538613 - Study of People With Metastatic Gastrointestinal Epithelial Cancer Administering Tumor-Infiltrating Lymphocytes in Which the Gene Encoding CISH Was Inactivated Using the CRISPR/Cas9 System Phase 1/Phase 2
Recruiting NCT04426669 - 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 Phase 1/Phase 2