Study Summary
This trial is testing a new drug, N-803, to see if it can help control HIV-1 without the need for antiretroviral therapy.
Eligible Conditions
- HIV/AIDS
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 12 Secondary · Reporting Duration: At step 2 weeks 0, 1, 4, 7, 9, 10, 13, 16, 19, 22, 26, 32 and 46
Week 2
Cell-associated HIV-1 RNA
Measurement of HIV-1 reservoir (dQVOA)
Measurement of intact proviral DNA
Total HIV-1 DNA
Week 2
Measurement of plasma viremia by HIV-1 single copy assay
Week 2
PK parameters: AUC0-τ of 10-1074
PK parameters: AUC0-τ of VRC07-523LS
Proportion of participants with antidrug antibodies
Week 8
Proportion of participants with plasma HIV-1 RNA <200 copies/mL 8 weeks after interruption of ART
Week 4
Proportion of participants with plasma HIV-1 RNA <200 copies/mL at 4, 12 and 24 weeks after interruption of ART in Step 3
Week 22
Number of N-803 doses completed
Week 22
Proportion of participants requiring dose reduction
Week 52
Occurrence of a Grade ≥2 AE that is at least possibly related to VRC07-523LS or 10-1074
Week 52
Occurrence of a Grade ≥2 AE that is at least possibly related to N-803, as judged by the CMC
Occurrence of a Grade ≥3 adverse event (AE) that is at least possibly related to N-803, as judged by the Clinical Management Committee (CMC)
Week 100
Occurrence of a Grade ≥2 AE without regard to relationship to study treatment
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Arm A: N-803 only
1 of 2
Arm B: N-803 in combination with 10-1074 and VRC07-523LS
1 of 2
Experimental Treatment
46 Total Participants · 2 Treatment Groups
Primary Treatment: N-803 (IL-15 Superagonist) · No Placebo Group · Phase 1
Arm A: N-803 only
Biological
Experimental Group · 1 Intervention: N-803 (IL-15 Superagonist) · Intervention Types: BiologicalArm B: N-803 in combination with 10-1074 and VRC07-523LSExperimental Group · 3 Interventions: 10-1074, VRC07-523LS, N-803 (IL-15 Superagonist) · Intervention Types: Biological, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
10-1074
2019
Completed Phase 2
~150
VRC07-523LS
2019
Completed Phase 1
~280
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at step 2 weeks 0, 1, 4, 7, 9, 10, 13, 16, 19, 22, 26, 32 and 46
Who is running the clinical trial?
Rockefeller UniversityOTHER
150 Previous Clinical Trials
16,817 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,151 Previous Clinical Trials
4,959,896 Total Patients Enrolled
ImmunityBio, Inc.Industry Sponsor
54 Previous Clinical Trials
5,009 Total Patients Enrolled
Timothy Wilkin, MD, MPHStudy ChairWeill Medical College of Cornell University
1 Previous Clinical Trials
530 Total Patients Enrolled
Eligibility Criteria
Age 18 - 65 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:People who are taking ART that includes an integrase inhibitor and two nucleoside reverse transcriptase inhibitors (NRTIs) or dolutegravir/lamivudine for at least 6 weeks prior to randomization are eligible for the study.
The patient must have a CD4 cell count nadir of ≥200 cells/mm^3.
The patient had a QTcF interval ≤440 msec within 90 days prior to randomization.
For women who are not pregnant and men who have not had a vasectomy, a negative urine or serum pregnancy test within 30 days prior torandomization is required.
The IC90 to 10-1074 of ≤1.5 mcg/mL, 10-1074 maximum percent inhibition (MPI) ≥98%, and IC80 to VRC07-523LS of ≤1 mcg/mL on the Monogram PhenoSense assay means that the virus is inhibited by less than 1.5 mcg/mL, the virus is inhibited by 98% or more, and the virus is inhibited by less than 1 mcg/mL, respectively.
A CD4 cell count of more than 450 cells per millimeter cubed within 90 days prior to randomization is required.
You have HIV-1 infection.
For at least 96 weeks prior to the start of the study, all participants were treated with ART.
Plasma HIV-1 RNA levels of <50 copies/mL for at least 96 weeks prior to randomization.
Select all results within 90 days of when you were randomly assigned to a study group.
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Conditions
Cancer Related
Treatments