# Immune Monitoring and BiKE Production Core

> **NIH NIH P01** · UNIVERSITY OF MINNESOTA · 2020 · $122,025

## Abstract

The overall goal of this program project grant is to understand how to best use natural killer (NK) cells for 
cancer therapy. This core will support Projects 1-3 by carrying out three essential tasks. Specifically, Core D 
personnel will perform three key roles that are necessary for the overall success of this proposal: 1) centralized 
processing of NK cell and peripheral blood stem cell (PBSC) product for clinical trials, 2) comprehensive 
immune monitoring of cell products and patient samples to assess the effectiveness of the experimental 
therapies and 3) large scale, good manufacturing practice (GMP)-compliant production of bispecific killer 
engager (BiKE) small molecules. Core D personnel will work closely with the research staff from Administrative 
core (Core A), the Biostatistics groups (Core B) and the Bioinformatics and Data Management staff (Core C) to 
facilitate the shipping of outbound clinical products and receipt of inbound research samples from multicenter 
clinical trials. Additionally, in collaboration with Core C, we will house and catalogue immune monitoring data 
and cryopreserved samples from the clinical trials outlined Project 3 (Weisdorf). This Core will also distribute 
samples for laboratory study by the investigators on Projects 1 (Parham) and 2 (Miller). With the assistance 
from the Biostatistics Core (Core B) and Bioinformatics and Data Management Core (Core C), these samples 
will be linked to complete and accurate immune monitoring data as well as clinical outcomes, thus assuring our 
ability to connect basic laboratory findings with clinical results. The impact of this core will be to seamlessly 
integrate the production and delivery of cell products for clinical trials, to ensure sample collection/distribution, 
to perform sophisticated immune monitoring and to create novel, biological drugs/small molecules (BiKEs) 
used for the proposed clinical trials. With this approach, Core D ensures uniform monitoring of clinical samples 
using good laboratory practice (GLP)-compliant methods, as well as high-quality research samples from 
clinical trials to be distributed to the research Projects of this PPG. By housing the above functions in a single 
core, sample processing and analysis will be consistent and cost-effective as we leverage existing institutional 
support and resources. Consequently, costs will be reduced by economy of scale (i.e., lower cost to run a large 
amount of samples) and sample processing/analysis will be consistent, thus, ensuring rigorous scientific 
oversight.

## Key facts

- **NIH application ID:** 9905398
- **Project number:** 5P01CA111412-15
- **Recipient organization:** UNIVERSITY OF MINNESOTA
- **Principal Investigator:** Michael R. Verneris
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $122,025
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9905398

## Citation

> US National Institutes of Health, RePORTER application 9905398, Immune Monitoring and BiKE Production Core (5P01CA111412-15). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9905398. Licensed CC0.

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