ReachMD

Approximately 38 million people globally are currently living with HIV, and according to UNAIDS, 650,000 people died from AIDS-related illnesses worldwide in 2021. In an attempt to find a cure for this deadly disease, a novel study for HIV is being conducted by UC Davis Health researchers.

They have dosed the second participant in their clinical trial utilizing CAR T-cell therapy, which has successfully treated cancer and lupus. This treatment involves modifying a patient’s white blood cells, which are called T-cells, to control the virus without medication by identifying and targeting HIV cells.

This open-label trial will consist of three cohorts with three HIV-positive patients over the age of 18 with an undetectable HIV viral load for 12 months and who have continuously been receiving antiretroviral therapy for a minimum of 12 months. Each group of patients will receive different treatments and dosing. There is the potential of 18 patients being studied in the expansion cohort. After three participants have completed the 45-day safety evaluation period, an increase in the patient’s dosage could be possible.

The characteristics of cohort 1 include:

• Infusion of a single dose of 3 x 10⁵ cells/kg LVgp120duoCAR T cells will be infused
• Antiretroviral therapy will be stopped immediately after infusion

The characteristics of cohort 2 include:

• Patients undergo non-ablative conditioning with cyclophosphamide
• Infusion of a single dose of 3 x 10⁵ cells/kg LVgp120duoCAR T cells
• Antiretroviral therapy will be stopped immediately after infusion

The characteristics of cohort 3 include:

• Patients undergo non-ablative conditioning with cyclophosphamide
• Infusion of a single dose of 1 x 10⁶ cells/kg LVgp120duoCAR T cells
• Antiretroviral therapy will be stopped immediately after infusion

The goal of this study is to assess the safety and tolerability of varying single-dose regimens of CAR T-cell therapy, which could have big impacts for those living with HIV.