# Cell-based Immunotherapy Products

> **NIH NIH N02** · LEIDOS BIOMEDICAL RESEARCH, INC. · 2024 · $13,633,885

## Abstract

The Division of Cancer Treatment and Diagnosis (DCTD), NCI, is requesting support to manufacture cell-based immunotherapy products for multi-center clinical trials and to use tumor biopsies from these trials to evaluate the pharmacodynamics (PD) of the cell products and provide proof of mechanism (POM). This should include capacity for process development; retrovirus, lentivirus, or other vector production; autologous and/or allogeneic cell therapy production; quality control and quality assurance systems to support these activities. It should also include development and validation of clinical PD biomarker assays that are fit-for-purpose for monitoring cell product mechanism of action, its modulation by possible combination regimens, and the natural response of endogenous (unmodified) T-cell and NK cell subpopulations to solid tumors and lymphoma (excludes leukemias). DCTD/NCI, is seeking to develop a current Good Manufacturing Practices (cGMP) cell therapy manufacturing resource at the Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research (FNLCR) in Frederick, MD. These products should be suitable for use in Phase I/II human clinical trials or advanced preclinical animal testing and their mechanism of action (MOA) be evaluable using PD biomarkers.

## Key facts

- **NIH application ID:** 11181130
- **Project number:** 261201500003I-P00011-26100077-1
- **Recipient organization:** LEIDOS BIOMEDICAL RESEARCH, INC.
- **Principal Investigator:** Gautam (George) Mitra
- **Activity code:** N02 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $13,633,885
- **Award type:** —
- **Project period:** 2018-09-24 → 2029-08-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11181130

## Citation

> US National Institutes of Health, RePORTER application 11181130, Cell-based Immunotherapy Products (261201500003I-P00011-26100077-1). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/11181130. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*