IL-15 Superagonist + Antibodies for HIV/AIDS
Trial Summary
What is the purpose of this trial?
The purpose of this study is to evaluate the safety, tolerability, and efficacy of N-803, an IL-15 superagonist, with or without combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic treatment interruption (ATI).
Will I have to stop taking my current medications?
The trial requires participants to be on a specific ART regimen with an integrase inhibitor and two NRTIs or dolutegravir/lamivudine. If you are on a different ART regimen, you may need to change your medications to meet this requirement.
What data supports the effectiveness of the drug IL-15 Superagonist + Antibodies for HIV/AIDS?
Research shows that the IL-15 superagonist N-803 can activate immune cells, like CD8+ T cells and natural killer cells, which are important for fighting HIV. In studies, N-803 has been shown to reduce the amount of virus in the body temporarily and enhance the immune response, suggesting potential benefits in managing HIV.12345
Is the IL-15 superagonist N-803 safe for humans?
In a phase 1 trial with people living with HIV, the IL-15 superagonist N-803 was generally safe, with the most common side effects being mild rash at the injection site and swollen lymph nodes. Some participants experienced minor changes in heart rhythm, but no serious lab-related side effects were linked to the drug.23456
How is the drug N-803 different from other HIV treatments?
N-803 is unique because it is an IL-15 superagonist that enhances the immune system's ability to fight HIV by boosting the activity of T cells and natural killer cells, potentially reducing the virus reservoir. Unlike standard antiretroviral therapy, which suppresses the virus, N-803 aims to activate latent virus and improve immune response, offering a novel approach to managing HIV.14567
Research Team
Timothy Wilkin, MD, MPH
Principal Investigator
Weill Medical College of Cornell University
Eligibility Criteria
This trial is for adults with HIV/AIDS who've been on ART including an integrase inhibitor and NRTIs or dolutegravir/lamivudine for at least 96 weeks, have a stable CD4 count, no history of AIDS-defining illness except recurrent pneumonia, and agree to use contraception. They must not be pregnant, breastfeeding, or have used immunomodulatory meds recently.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive N-803 with or without combination bNAbs for HIV-1 control
Analytic Treatment Interruption (ATI)
Participants interrupt antiretroviral therapy and are monitored closely
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- 10-1074
- N-803
- VRC07-523LS
N-803 is already approved in United States for the following indications:
- Non-muscle invasive bladder cancer (NMIBC) in combination with BCG
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Rockefeller University
Collaborator
ImmunityBio, Inc.
Industry Sponsor
Richard Adcock
ImmunityBio, Inc.
Chief Executive Officer since 2024
Information not available
Dr. Patrick Soon-Shiong
ImmunityBio, Inc.
Chief Medical Officer since 2021
MD