Grant Award Details
Manufacturing and IND enabling preclinical studies to support a phase 1 trial of CMV-specific T cells expressing anti-HIV CAR and CMV vaccine boost as immunotherapy for HIV/AIDS
Grant Application Details
- CMV-specific T cells expressing anti-HIV CAR and CMV vaccine boost as immunotherapy for HIV/AIDS
Therapeutic Candidate or Device
Cytomegalovirus (CMV)-reactive T cells that express chimeric antibody receptors (CARs) to recognize and kill HIV-infected cells
Antiretroviral drug therapy (ART) suppresses HIV to undetectable levels but does not eradicate the cellular reservoirs of the virus. We will engineer HIV-specific CAR T cells that will kill reactivated HIV-infected cells after ART withdrawal. These cells are also engineered to proliferate in response to a cytomegalovirus (CMV) . We will use a CMV vaccine to maintain these CAR T cells when HIV viremia is low, i.e., before ART withdrawal or when the HIV reactivation is controlled.
Unmet Medical Need
There is no cure for HIV and only half of the HIV patients adhere to ART in North America. Every year, ~16,000 HIV individuals die in the U.S. Our long-term goal is to develop a highly effective immunotherapy which significantly improves outcomes for HIV individuals and eliminate the need for ART.
IND filing and initiation of Phase 1 trial sites
Major Proposed Activities
- Optimize the clinical-manufacturing of the therapeutic product
- Complete the characterization of the efficacy and safety profiles of the therapeutic product
- Submit the regulatory documentation to initiate the clinical trial
HIV represents a major health and economic burden for CA. In 2016, CA had the highest number of newly diagnosed HIV cases in the US. This year, the CA Department of Public Health estimates medication expenditures of $338M for individuals who don’t have private insurance, Medi-Cal or Medicare. This represents a $23.1M increase over last year, due to higher medication costs and an increase in Californians living with HIV. A curative treatment will have a significant benefit to the taxpayers of CA.
- Mol Ther Methods Clin Dev (2022) Pre-clinical data supporting immunotherapy for HIV using CMV-HIV-specific CAR T cells with CMV vaccine. (PubMed: 35573050)
- J Virol (2022) Novel Humanized Peripheral Blood Mononuclear Cell Mouse Model with Delayed Onset of Graft-versus-Host Disease for Preclinical HIV Research. (PubMed: 34818071)