# Cell Therapy Core: GMP/Vector Labs

> **NIH NIH P01** · UNIVERSITY OF TX MD ANDERSON CAN CTR · 2021 · $404,186

## Abstract

PROJECT SUMMARY
This Program Project Grant (PO1) explores the enhancement of cord blood transplantation (CBT) by
employing ex-vivo expansion of CB stem/progenitors, natural killer (NK) cells and T cells engineered to
express chimeric antigen receptors (CARs), and virus-specific T cells in preclinical studies and clinical trials. All
four projects will undertake clinical trials during the course of the studies. These rely on the availability of a
GMP manufacturing facility for the preparation of the cellular therapy products. Projects 1, 3 and 4 will use on
the Good Manufacturing Practice (GMP) Facility at MD Anderson Cancer Center (MDACC) and Project 2 will
rely on the GMP Facility at Children's National Medical Center (CNHS)-Cell Enhancement and Technologies
for Immunotherapy (CETI). The GMP Facility at MDACC has been in operation for more than 15 years and the
GMP at CNHS-CETI is a new facility, which opened in 2013. The Cell Processing Facilities at both institutions
have considerable experience in the preparation of a wide variety of cellular products and both received more-
than-minimal cell therapy accreditation from the Foundation for the Accreditation of Cellular Therapy (FACT).
Both Facilities are well equipped to operate under GMP conditions, with extensive documentation systems,
barcoding, environmental monitoring, and quality assurance, control and improvement programs. An
independent and validated alarm system is provided in both facilities to monitor, log and alarm the temperature
in all incubators, refrigerators and freezers; the airflow in each biosafety cabinet; and differential pressure
across doors between the ISO 7 and ISO 8 laboratories. Additional components of the Core are the Quality
Control Laboratories at CNHS-CETI and MDACC, which perform in-house testing of cellular products, and are
responsible for routine monitoring of the GMP Laboratory and Quality Assurance Group to ensure compliance
with cGMP regulations and provides independent overview of all aspects of manufacturing and release. The
GMP personnel at both institutions have extensive regulatory experience that will facilitate the translational of
laboratory studies into clinical trials. In this proposal, MDACC will manufacture five cellular therapy products.
For Project 1: expanded CB cells that have been fucosylated to enhance engraftment, and fucosylated
mesenchymal stromal cells (MSCs) to treat graft versus host disease. For Project 3: CB NK cells genetically
modified to express a chimeric antigen receptor (CAR) targeting CD19+ lymphoid cancers which expresses IL-
15, and an inducible caspase 9 suicide gene. For Project 4: CB T cells expressing a CAR targeting Pr1+
myeloid cancers. For Project 2: CNHS-CETI will manufacture CB multi-virus-specific T cells targeting CMV,
EBV, adenovirs and BK virus, as well as the novel HIV-specific T cell product which will be used for patients
with HIV disease.. In summary, the GMP Laboratory Core is a vital component of the P...

## Key facts

- **NIH application ID:** 10247035
- **Project number:** 5P01CA148600-10
- **Recipient organization:** UNIVERSITY OF TX MD ANDERSON CAN CTR
- **Principal Investigator:** Indreshpal Kaur
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $404,186
- **Award type:** 5
- **Project period:** 2011-09-22 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10247035

## Citation

> US National Institutes of Health, RePORTER application 10247035, Cell Therapy Core: GMP/Vector Labs (5P01CA148600-10). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10247035. Licensed CC0.

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