# Core B - Cell Engineering and Manufacturing Facility

> **NIH NIH P01** · UNIVERSITY OF PENNSYLVANIA · 2024 · $455,618

## Abstract

Core B Summary
Core B comprises two interrelated laboratories: the Clinical Cell and Vaccine Production Facility (CVPF), a GMP-
compliant cell manufacturing facility, and an associated Antibody Development Laboratory (ADL) that is devoted
to the discovery and design of novel CAR-T constructs for use by P01-proposed projects. The CVPF is a
Foundation for the Accreditation of Cellular Therapy (FACT)-accredited facility and is the only GMP-compliant
cell manufacturing facility on the University of Pennsylvania campus providing the university community with
integrated scientific, technical, and regulatory expertise to support manufacturing of biologics for in-human Phase
I and II clinical trials. The ADL is new to this P01 renewal application and will support the three scientific projects
by developing novel chimeric antigen receptor binding domains to complement those that are currently available
to the projects. Core B has four specific aims. In Aim 1, the CVPF will support Project 1 by providing 3-day
manufacturing, validation, and cryopreservation of CRISPR-mediated knockout of CD5 in CD19-directed CAR-
T cells for use in a clinical trial for relapsed/refractory CLL and NHL patients. In Aim 2, the CVPF will support
Project 2 by manufacturing, validating, and cryopreserving CD45 base-edited CD34+ hematopoietic stem cells
and CD45-directed CAR-T cells for use in a clinical trial for AML patients. In Aim 3, the CVPF will support Project
3 by manufacturing, validating, and cryopreserving BCMA-directed CAR-T cells from marrow infiltrating
lymphocytes (MILs) for comparison with conventional peripheral blood-derived BCMA-directed CAR-T cells
produced in parallel for use in a clinical trial for multiple myeloma patients. In Aim 4, the ADL will use antibody
phage display technology to construct and screen libraries derived from llamas immunized with CD5, CD45, and
BCMA in order to isolate single-domain VHH antibody fragments optimized with respect to affinity and other
desired functional properties as needed for use in Projects 1, 2, and 3.

## Key facts

- **NIH application ID:** 10931429
- **Project number:** 5P01CA214278-07
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** DONALD Lawrence SIEGEL
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $455,618
- **Award type:** 5
- **Project period:** 2017-08-15 → 2028-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10931429

## Citation

> US National Institutes of Health, RePORTER application 10931429, Core B - Cell Engineering and Manufacturing Facility (5P01CA214278-07). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10931429. Licensed CC0.

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