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NCT05245292 · ClinicalTrials.gov registry record · Phase 1
3BNC117-LS and 10-1074-LS Plus N-803 (bNAb+N-803)
A Phase 1 study of Human Immunodeficiency Virus, sponsored by Rockefeller University.
- Active
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 3
- Study locations
NCT05245292: Active Phase 1 study of Human Immunodeficiency Virus, sponsored by Rockefeller University.
NCT05245292 is a Phase 1 study of Human Immunodeficiency Virus that is active but no longer recruiting, run by Rockefeller University. The registered enrollment target is 28 participants, below the 183-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (85% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05245292, a Phase 1 study of Human Immunodeficiency Virus, is active but no longer recruiting, sponsored by Rockefeller University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 3
- Study locations
Study Summary
The proposed study is a phase 1, open label, single arm study to evaluate the safety and antiretroviral activity of the combination of two long-acting broadly neutralizing antibodies, 3BNC117-LS dosed once at 30 mg/kg and 10-1074-LS dosed once at 10 mg/kg, both intravenously (IV) at week 0, plus an IL-15 superagonist complex, N-803, dosed at 6 mcg/kg, subcutaneously (SC) at week 1 and then every 3 weeks for a total of 8 doses, in ART-treated adults living with HIV during analytical treatment interruption.
Primary Outcome
The number of participants with treatment-related solicited and unsolicited grade 3 and serious adverse events (including confirmed laboratory abnormalities), or premature study treatment discontinuation due to an adverse event (regardless of grade).
Conditions Studied
Interventions
- DRUG N803
- DRUG 3BNC117-LS
- DRUG 10-1074-LS
Study Locations (3)
New York
- Weill Cornell Medicine, Cornell Clinical Trials Unit - New York
- The Rockefeller University - New York
Pennsylvania
- Perelman School of Medicine University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2022-12-07 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
What the registry record for NCT05245292 still lists
NCT05245292 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 183-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Human Immunodeficiency Virus appearing as the primary indexed condition, and to 3 interventions - of which N803 is the first listed.
NCT05245292 reports a single indexed study location in New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05245292 about?
NCT05245292 is a clinical study titled "3BNC117-LS and 10-1074-LS Plus N-803 (bNAb+N-803)". The proposed study is a phase 1, open label, single arm study to evaluate the safety and antiretroviral activity of the combination of two long-acting broadly neutralizing antibodies, 3BNC117-LS dosed once at 30 mg/kg and 10-1074-LS dosed once at 10 mg/kg, both intravenously (IV) at week 0, plus an ...
What is the current status of trial NCT05245292?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2022-12-07. Estimated completion is 2026-03-31.
What conditions does trial NCT05245292 study?
This clinical trial studies the following conditions: Human Immunodeficiency Virus.
What interventions are being tested in trial NCT05245292?
The interventions under investigation include: N803 (DRUG), 3BNC117-LS (DRUG), 10-1074-LS (DRUG).
Who is sponsoring clinical trial NCT05245292?
This trial is sponsored by Rockefeller University, which has 117 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05245292 being conducted?
This trial has 3 study locations across New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05245292's enrollment target sits among peer trials
28 29th of 39 higher than 11 of 39 other Human Immunodeficiency Virus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Human Immunodeficiency Virus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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