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NCT04648046 · ClinicalTrials.gov registry record · Phase 1
CAR-T Cells for HIV Infection
A Phase 1 study of HIV Infections, sponsored by Steven Deeks.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 2
- Study locations
NCT04648046 is a Phase 1 study of HIV Infections that is actively recruiting participants, run by Steven Deeks. The registered enrollment target is 18 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT04648046, a Phase 1 study of HIV Infections, is actively recruiting participants, sponsored by Steven Deeks.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a limited-center, open-label dose escalating phase I/IIa study of autologous T cells expressing LVgp120duoCAR molecules in people with HIV infection. It will follow a 3+3 design. Dose escalation decisions will be made when a minimum of three participants have completed the safety-evaluation period (45 days) at a given dose level. Cohort 1 will undergo infusion of a single low-dose regimen of LVgp120duoCAR-T cells. Cohort 2 will undergo non-ablative conditioning with cyclophosphamide, followed by infusion of a single low-dose regimen of LVgp120duoCAR-T cells. Cohort 3 will undergo non-ablative conditioning with cyclophosphamide, followed infusion of a single high-dose regimen of LVgp120duoCAR-T cells. Following administration of the experimental therapy, HIV medications will be paused for participants in each group during an analytic treatment interruption.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- BIOLOGICAL LVgp120duoCAR-T cells, low dose
- BIOLOGICAL LVgp120duoCAR-T cells, high dose
- OTHER Analytic Treatment Interruption
Study Locations (2)
California
- University of California, Davis - Sacramento
- Zuckerberg San Francisco General - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04648046
The ClinicalTrials.gov registry entry for NCT04648046 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower). The listed sponsor is Steven Deeks, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT04648046 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04648046 about?
NCT04648046 is a clinical study titled "CAR-T Cells for HIV Infection". This is a limited-center, open-label dose escalating phase I/IIa study of autologous T cells expressing LVgp120duoCAR molecules in people with HIV infection. It will follow a 3+3 design. Dose escalation decisions will be made when a minimum of three participants have completed the safety-evaluation ...
What is the current status of trial NCT04648046?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2021-03-01. Estimated completion is 2029-12-31.
What conditions does trial NCT04648046 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT04648046?
The interventions under investigation include: Cyclophosphamide (DRUG), LVgp120duoCAR-T cells, low dose (BIOLOGICAL), LVgp120duoCAR-T cells, high dose (BIOLOGICAL), Analytic Treatment Interruption (OTHER).
Who is sponsoring clinical trial NCT04648046?
This trial is sponsored by Steven Deeks, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04648046 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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