# Core A: Administrative and Clinical Translational Core

> **NIH NIH P01** · UNIVERSITY OF PENNSYLVANIA · 2024 · $300,498

## Abstract

SUMMARY CORE A: ADMINISTRATIVE AND CLINICAL TRANSLATIONAL CORE
The Administrative and Clinical Translational Core of this renewal Program Project will provide: (1) scientific
and clinical operational oversight; (2) IND-enabling regulatory and clinical development expertise, and
biostatistical and budgetary structure to support effective operations for each P01 Project and Scientific Core;
and (3) promote project integration and synergy. This renewal proposal seeks to build upon our proven track
record in genetically engineered T cell therapy by enhancing the chimeric antigen receptor T cell platform to
specifically address systemic vulnerabilities that we have observed in our clinical trials to date. Our
overarching hypothesis is that novel gene editing approaches can remove the remaining obstacles in the path
of universally-available and universally-active CAR T cell therapy for hematologic malignancy. We have
brought together a cadre of exceptional investigators who have collaborated and published together for many
years. Each disease-focused project will be led by a recognized authority in the field. The three cores that
support this proposal have been critical to the success of our clinical CAR T cell program to date and their
expertise will underpin the success of this proposal. The centerpiece of each project is an innovative clinical
trial that seeks to test our major hypotheses.
We are leveraging the proven translational infrastructure, administrative staff and the centralized research
organizations at the Center for Cellular Immunotherapies at the Perelman School of Medicine to achieve our
objectives. Strong institutional commitment from the Abramson Cancer Center, Perelman School of Medicine,
the Parker Institute for Cancer Immunotherapy and the University of Pennsylvania have facilitated our
scientific and translational achievements. The essential services provided by Core A include administrative
support for all investigators in each project and core; fiscal management and oversight for all components of
the Program Project; clinical protocol development, IND submissions and maintenance, and clinical data
management; and organization and communication of all Program Project meetings and activities. The overall
goal of this Core is effective and efficient leadership of the P01. The roles of the Director, Co-investigators
and administrative staff are to facilitate communication and organizational structure while stimulating scientific
and technological interactions. In order to achieve this goal, the Core has established four objectives: (1) To
oversee the safety and monitoring activities for Penn and CHOP clinical sites; (2) To provide regulatory,
preclinical development, and statistical support for clinical trials, projects and cores and implement data
sharing plans.; (3) To coordinate the interactions among clinicians and scientists in projects and cores, internal
and external advisory boards, and NCI personnel regarding effective im...

## Key facts

- **NIH application ID:** 10931427
- **Project number:** 5P01CA214278-07
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** CARL H. JUNE
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $300,498
- **Award type:** 5
- **Project period:** 2017-08-15 → 2028-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10931427

## Citation

> US National Institutes of Health, RePORTER application 10931427, Core A: Administrative and Clinical Translational Core (5P01CA214278-07). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10931427. Licensed CC0.

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