Evaluation of Safety and Feasibility of Cytomegalovirus-Specific, Anti-HIV Chimeric Antigen Receptor (CMV/HIV-CAR) T Cells in People with HIV
Grant Award Details
Grant Type:
Grant Number:
CLIN2-14748
Investigator(s):
Institution:
Type:
PI
Disease Focus:
Human Stem Cell Use:
Award Value:
$11,299,976
Status:
Active
Grant Application Details
Application Title:
Evaluation of Safety and Feasibility of Cytomegalovirus-Specific, Anti-HIV Chimeric Antigen Receptor (CMV/HIV-CAR) T Cells in People with HIV
Public Abstract:
Therapeutic Candidate or Device
Cytomegalovirus (CMV)-specific T cells that express a chimeric antigen receptor (CAR) which targets and eliminates HIV-infected cells
Indication
Management of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)
Therapeutic Mechanism
Persons with HIV (PWH) lose immunity because of decreased T lymphocyte function. We propose to treat them with CAR T cells which will attack and eliminate HIV-infected cells. These cells will also be able to recognize and be activated by cytomegalovirus (CMV) which is present in most PWH. We propose to harness this natural system (an endogenous source of CMV signaling) for maintaining sufficient numbers of these CAR T cells at levels that could control HIV infection in the absence of ART.
Unmet Medical Need
In US, despite advanced therapies, HIV is still a persistent public health problem, with an estimated 1.2 million PWH in 2019. There is no cure for HIV. A highly effective immunotherapy could significantly improve outcomes for HIV-infected individuals and eliminate the need for ART.
Project Objective
A pilot Phase 1 trial completed
Major Proposed Activities
Cytomegalovirus (CMV)-specific T cells that express a chimeric antigen receptor (CAR) which targets and eliminates HIV-infected cells
Indication
Management of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)
Therapeutic Mechanism
Persons with HIV (PWH) lose immunity because of decreased T lymphocyte function. We propose to treat them with CAR T cells which will attack and eliminate HIV-infected cells. These cells will also be able to recognize and be activated by cytomegalovirus (CMV) which is present in most PWH. We propose to harness this natural system (an endogenous source of CMV signaling) for maintaining sufficient numbers of these CAR T cells at levels that could control HIV infection in the absence of ART.
Unmet Medical Need
In US, despite advanced therapies, HIV is still a persistent public health problem, with an estimated 1.2 million PWH in 2019. There is no cure for HIV. A highly effective immunotherapy could significantly improve outcomes for HIV-infected individuals and eliminate the need for ART.
Project Objective
A pilot Phase 1 trial completed
Major Proposed Activities
- Manufacture product to supply the proposed trial
- Assess clinical safety of the therapeutic product
- Data collection, analysis and report
Statement of Benefit to California:
HIV is a life-long chronic disease with a huge financial burden for CA. In 2020, CA had the highest number of PWH in the US, and in fiscal 2023-24, will spend $438.1M on its AIDS Drug Assistance Program to help individuals who are uninsured or under-insured, have access to antiviral therapy (ART). A curative treatment which eliminates the lifelong need for ART would have a significant benefit to the taxpayers of CA.