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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: Recruiting Phase 1 study of HIV Infections, sponsored by Steven Deeks.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary safety outcome will be the number of participants reporting a new Grade 3 or greater adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, including signs/symptoms, lab toxicity or clinical event, that is definitely, probably, or possibly related to study treatment within 1 year of product administration.
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 |
What NCT04648046 shows while recruiting
NCT04648046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04648046's enrollment target sits among peer trials
18 504th of 542 higher than 31 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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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