# Core C: Clinical Management and Resources

> **NIH NIH P01** · ROSWELL PARK CANCER INSTITUTE CORP · 2024 · $350,663

## Abstract

ABSTRACT
Core C (Clinical), directed by Dr. Igor Puzanov, MD, will provide integrated oversight, support and coordination
for all clinical components of this P01. It will support the implementation and completion of the clinical trials
performed within this Program, production and distribution of the cGMP vaccines, immune monitoring of patients
and collection of clinical data. Dr. Puzanov will lead Subcore C1 (Regulatory and Clinical Trial Management),
being supported by Dr. Edwards (Magee site). He will be assisted by Drs. Kalinski and Chodon, who will be
responsible for cGMP production of dendritic cell (DC) vaccines (C2. Dendritic Cell Production) and by Drs.
Odunsi, Matsuzaki and Vlad, who will assure effective immune monitoring of the patients on the clinical trials
performed within this Program (C3. Immune Monitoring). The Specific Aims of Core C are:
Aim 1: Clinical and Regulatory Management. The efforts of Core C1 will focus on a) Assurance that the clinical
trials performed within this P01 are approved by the necessary regulatory bodies and that all reporting
requirements are met; b) Assurance that the clinical trial will be timely implemented, efficiently completed and
properly analyzed; c) Assurance that the correlative and mechanistic studies have access to patient material;
and d) fully-integrated development of the follow-up clinical trials, based on the results of all 3 Projects and the
results of our other studies held at Roswell Park Cancer Institute (RPCI) and U. Pittsburgh.
Aim 2: cGMP production of dendritic cell (DC) vaccines. Core C2 will assure: a) Logistic oversight for the
collection of patients’ tumor and leukapheresis material to the cGMP cell production facility; b) Production of
antigen-loaded dendritic cell (DC) vaccines for therapy of patients, in accordance with the clinical protocols and
cGMP guidelines; c) Characterization, release and delivery of DC vaccines for the clinical trials; and d) Continued
improvement of the process of DC production, testing, preservation, and distribution, to enhance the potency of
the cellular products, streamline the process and limit the costs.
Aim 3: Immune monitoring and cell analyses. Core C3 will provide: a) Procurement, triage and processing of
human blood specimens for use in laboratory studies associated with this Program; b) Monitoring patients’
systemic (blood) immunologic responses in clinical trials; and c) (Developmental) Identification of the most
relevant biomarkers (blood and biomarkers of the individual DC vaccines) predictive of clinical responses.
Programmatic Role and Interactions. Core C will support the timely completion of the three clinical trials proposes
in years 1-3, coordinated analysis of their (local and clinical) efficacy and potential side effects (with Cores B and
D). Based on these data and results of laboratory studies from all three projects, in year 3, Core C will help to
finalize the designs of the clinical trials proposed in SA3s of Projects 1 ...

## Key facts

- **NIH application ID:** 10916170
- **Project number:** 5P01CA234212-04
- **Recipient organization:** ROSWELL PARK CANCER INSTITUTE CORP
- **Principal Investigator:** Igor Puzanov
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $350,663
- **Award type:** 5
- **Project period:** 2020-03-03 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10916170

## Citation

> US National Institutes of Health, RePORTER application 10916170, Core C: Clinical Management and Resources (5P01CA234212-04). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10916170. Licensed CC0.

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