Comprehensive Immune Monitoring of Clinical Trials to Advance Human Immunotherapy

Cell Rep. 2019 Jul 16;28(3):819-831.e4. doi: 10.1016/j.celrep.2019.06.049.

Abstract

The success of immunotherapy has led to a myriad of clinical trials accompanied by efforts to gain mechanistic insight and identify predictive signatures for personalization. However, many immune monitoring technologies face investigator bias, missing unanticipated cellular responses in limited clinical material. We present here a mass cytometry (CyTOF) workflow for standardized, systems-level biomarker discovery in immunotherapy trials. To broadly enumerate immune cell identity and activity, we established and extensively assessed a reference panel of 33 antibodies to cover major cell subsets, simultaneously quantifying activation and immune checkpoint molecules in a single assay. This assay enumerates ≥98% of peripheral immune cells with ≥4 positively identifying antigens. Robustness and reproducibility are demonstrated on multiple samples types, across two research centers and by orthogonal measurements. Using automated analysis, we identify stratifying immune signatures in bone marrow transplantation-associated graft-versus-host disease. Together, this validated workflow ensures comprehensive immunophenotypic analysis and data comparability and will accelerate biomarker discovery.

Keywords: CyTOF; biomarker; bone marrow transplantation; cancer; immunotherapy; mass cytometry; monitoring; phenotyping.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Biomarkers / analysis
  • Clinical Trials as Topic*
  • Female
  • Graft vs Host Disease / immunology
  • Humans
  • Immunophenotyping / methods*
  • Immunophenotyping / standards
  • Immunotherapy / methods*
  • Male
  • Middle Aged
  • Monitoring, Immunologic / methods*
  • Monitoring, Immunologic / standards
  • Neoplasms / immunology
  • Neoplasms / therapy
  • Reference Standards

Substances

  • Biomarkers