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An open label, single arm study of the safety and antiretroviral activity of the combination of 2 long-acting broadly neutralizing antibodies plus an IL-15 superagonist complex in ART-treated adults living with HIV during analytical treatment interruption

Clinical Trial Details

The purpose of this research study is to evaluate whether the 3 experimental study drugs being tested, 3BN117-LS, 10-1074-LS and N-803, are safe and tolerable for participants with HIV. Experimental means that these drugs have not yet been approved by the U.S. Food and Drug Administration (FDA). This study will also look at how well HIV is controlled after stopping antiretroviral therapy (ART).

Antibodies are naturally made by the body and help fight diseases. Two of the drugs being tested in this study, 3BNC117-LS and 10-1074-LS, are antibodies made in the laboratory. These study drugs attach to HIV and can lower the amount of HIV (viral load) in the blood. 
   
The third study drug, N-803, is an experimental drug that can stimulate cells of the immune system to increase in number and activity. In the future, the combination of these study drugs may be used to treat HIV infection. 
   
Participants will receive one dose of the two study antibodies as intravenous infusions and up to eight injections of N-803. Participants will be expected to come in for study visits to have blood samples collected, as well as undergoing two to four leukapheresis procedures at 6-month intervals. Leukapheresis is a several-hours-long procedure in which blood is collected from a vein in one of the arms, processed through an attached machine, and then returned through a vein in the opposite arm. 

Participants will also be expected to discontinue their HIV medications for a period of time. 
 
In addition to evaluating if the study drugs are safe and can keep the viral load low when ART is stopped, this study will also measure the ways cells in the immune system fight HIV. The study will also measure the time it takes for the two study antibodies, 3BNC117-LS and 10-1074-LS, to be cleared from the body, as well as study the expression of participants’ genes.    

Total study participation will last approximately 18 months.

Key Eligibility: 

  1. Aged 17-80 years old
  2. A confirmed diagnosis of HIV 
  3. On ART consistently for approximately 2 years 
  4. Willing to participate in a closely monitored ART interruption. 

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Jonathan Berardi, NP
212-746-4177
jlb4002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2203024539

ClinicalTrials.gov:

NCT05245292

Sponsor:

MCA-1031

Status

Open to Enrollment

Age Group

Adult

Sponsor