# Clinical Trials Engine to Develop an HIV Cure study to test engineered T cells

> **NIH NIH U19** · UNIVERSITY OF PENNSYLVANIA · 2022 · $337,135

## Abstract

Project 4 - Abstract
The principle that adoptively transferred T lymphocytes have therapeutic promise for HIV infection
is well established. Our long range goals are to engineer T cells so that they can control HIV-1
replication in the absence of HAART. Our companies’ scientific founders have pioneered the use
of cell and gene therapy to treat HIV-1, and we will use this expertise to better study the
relationship between T cells that have been rendered resistant to HIV-1 infection and specific for
HIV to control of HIV-1 replication in the absence of ART. Our project serves as a main integration
site for this U19 consortium as the most promising approaches generated by Projects 1-3 will be
incorporated into Phase I clinical trial that we design, execute and analysis. Additionally, we will
develop a commercial T cell manufacturing platform that will give HIV infected individuals access
to Chimeric Antigen Receptor (CAR) therapy. The specific aims of this Project are: 1) Define the
optimal method to expand T cells for HIV cure studies: Using Tmunity’s T cell expansion expertise
and proprietary technology, we will systematically address the best media, artificial APC, and
manufacturing platform to develop an optimized protocol to expand highly functional T cells with
superior engraftment potential to be used as part of HIV cure regimens. 2) Design and
implement a Phase I clinical trial to test the ability of engineered T cells to prevent viral
rebound during an analytical treatment interruption: With input from the members of this U19,
scientific advisory board (SAB) and NIH program officers, we will plan and execute a Phase I
clinical trial that uses this new manufacturing protocol established in Aim 1. 3) Perform
correlative studies on samples collected in Aim 2 to develop testable hypotheses that
could improve adoptive T cell therapy for HIV infection: Using banked cells collected from
informative time points, we will perform validated assays that examine T cell function and
persistence and the ability of the chosen intervention to control HIV replication in the absence of
ART.

## Key facts

- **NIH application ID:** 10450653
- **Project number:** 5U19AI149680-03
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** CHRISTINA M COUGHLIN
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $337,135
- **Award type:** 5
- **Project period:** 2020-05-15 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10450653

## Citation

> US National Institutes of Health, RePORTER application 10450653, Clinical Trials Engine to Develop an HIV Cure study to test engineered T cells (5U19AI149680-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10450653. Licensed CC0.

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