# Human Immunologic Monitoring and cGMP

> **NIH NIH P30** · UNIVERSITY OF CHICAGO · 2020 · $4,735

## Abstract

ABSTRACT
The main purpose of the Human Immunologic Monitoring and Current Good Manufacturing Practice (HIM-
cGMP) Facility is to provide support to investigators at the University of Chicago Medicine Comprehensive
Cancer Center (UCCCC) who conduct immunotherapy clinical trials through preparing vaccines and other
novel immunotherapies for patient administration, and by evaluating various immunologic endpoints from
patient samples. The HIM Subcore was initiated in 1999 as a Developing Core and has been under continuous
direction by Thomas Gajewski, MD, PhD, since that time. In 2002, the HIM Core Facility became a full CCSG
Core. The cGMP Subcore was initiated as a UCCCC Developing Core in 2001 and has been under continuous
direction by Amittha Wickrema, PhD, since its inception. In 2011, the HIM Facility formally merged with the
cGMP Facility, which streamlined the interface between the two components, including shared technical staff.
With the increasing role of immunotherapy in the portfolio of cancer therapeutics, the activities of the HIM-
cGMP Facilty are vital for the scientific investigation of novel agen and have been expanding rapidly. In
addition to providing standard assays to measure immunologic endpoints and to monitor biologic effects of
other pharmacologic agents using lymphocytes as a surrogate tissue, the Facilty has integrated new
technologies to facilitate the study of novel biomarkers in patients. For example, UCCCC investigators first
described the T cell-inflamed/non-inflamed tumor microenvironment gene expression profile that has been
explored as a predictive biomarker for response to checkpoint blockade therapy. Understanding the
mechanism by which this spontaneous anti-tumor T cell response develops in some patients, and the
mechanism by which immune exclusion occurs in the remaining patients, is highlighting mechanisms of
resistance and new therapeutic targets. The HIM-cGMP Facility has integrated new technologies that are
facilitating identification of these mechanisms. The Facility recently purchased a Nanostring nCounter
instrument, which enables gene expression profiling from formalin-fixed paraffin-embedded (FFPE) tissue, as
well as an RNAscope system, for visualizing in situ expression of specific mRNAs. In addition, new protocols
for banking stool for microbiota sequencing, blood for germline DNA analysis, and serum for specialized
biochemical assays have been developed. Thus, in addition to standard immunologic assays, the HIM-cGMP
Facility is facilitating the analysis of multidimensional correlations between mutational patterns in the tumor,
germline genetic polymorphisms, and the composition of intestinal micriobiota, all with respect to
immunotherapy clinical outcome.

## Key facts

- **NIH application ID:** 10178296
- **Project number:** 3P30CA014599-45S2
- **Recipient organization:** UNIVERSITY OF CHICAGO
- **Principal Investigator:** THOMAS F GAJEWSKI
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $4,735
- **Award type:** 3
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10178296

## Citation

> US National Institutes of Health, RePORTER application 10178296, Human Immunologic Monitoring and cGMP (3P30CA014599-45S2). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10178296. Licensed CC0.

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