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CAR T-cell Therapy

CAR-T Cell Therapy for HIV

Phase 1 & 2
Recruiting
Led By Steven Deeks, MD
Research Sponsored by Steven Deeks
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
On continuous antiretroviral therapy for at least 12 months without any interruptions of greater than 14 consecutive days, and on a stable regimen that does not include a non-nucleoside reverse transcriptase inhibitor (NNRTI) for at least 4 weeks or any long-acting ART drug that may be active in the participant after ART interruption for up to one year, without plans to modify ART during the study period
HIV-1 infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 year of product administration
Awards & highlights

Study Summary

This trial will test a new treatment for HIV that involves modifying a patient's own T cells to attack the virus. The treatment will be given in escalating doses to see what is safe and effective.

Who is the study for?
This trial is for adults aged 18-65 with HIV who've been on stable antiretroviral therapy (ART) without interruptions for at least a year. They must have undetectable viral loads, a history of good immune health indicated by CD4+ T cell counts, and be willing to pause their ART during the study. Excluded are pregnant or breastfeeding individuals, those unwilling to use birth control, people with certain cancers or hepatitis infections, and anyone on specific ART drugs that may interact poorly with the trial medications.Check my eligibility
What is being tested?
The study tests LVgp120duoCAR-T cells in three escalating doses to see how they affect HIV infection. Participants will either receive low-dose CAR-T cells alone or combined with cyclophosphamide conditioning; another group gets high-dose CAR-T after conditioning. The treatment's impact will be assessed during an analytic treatment interruption where standard HIV meds are paused.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion of CAR-T cells such as fever and fatigue, complications from cyclophosphamide like nausea and hair loss, and increased risk of infections due to pausing usual HIV treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've been on stable HIV treatment for over a year without breaks longer than 2 weeks.
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I am infected with HIV-1.
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I have a history of ART treatment and can follow an effective antiretroviral regimen.
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I am willing to stop my current HIV treatment for the study.
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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 year of product administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 year of product administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants achieving post-treatment control within 36 weeks of product administration.
Number of participants reporting a new Grade 3 or greater adverse event that is definitely, probably, or possibly related to study treatment within 1 year of product administration.
Secondary outcome measures
Change in quantitative virologic measures of the HIV reservoir pre- and post-therapy
Persistence of LVgp120duoCAR-T cells in blood during therapy
Persistence of LVgp120duoCAR-T cells in tissues during therapy

Trial Design

3Treatment groups
Experimental Treatment
Group I: Low Dose CAR-T Cells OnlyExperimental Treatment2 Interventions
Participants will NOT undergo non-ablative conditioning with cyclophosphamide. A single dose of 3 x 10^5 cells/kg LVgp120duoCAR-T cells will be infused. ART will be interrupted immediately after infusion.
Group II: Conditioning + Low Dose CAR-T CellsExperimental Treatment3 Interventions
Participants will undergo non-ablative conditioning with cyclophosphamide. A single dose of 3 x 10^5 cells/kg LVgp120duoCAR-T cells will be infused. ART will be interrupted immediately after infusion.
Group III: Conditioning + High Dose CAR-T CellsExperimental Treatment3 Interventions
Participants will undergo non-ablative conditioning with cyclophosphamide. A single dose of 1 x 10^6 cells/kg LVgp120duoCAR-T cells will be infused into the participant. ART will be interrupted immediately after infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

Steven DeeksLead Sponsor
1 Previous Clinical Trials
56 Total Patients Enrolled
Caring CrossUNKNOWN
Steven Deeks, MD5.01 ReviewsPrincipal Investigator - University of California, San Francisco
University of California, San Francisco
7 Previous Clinical Trials
1,106 Total Patients Enrolled

Media Library

LVgp120duoCAR-T cells, high dose (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04648046 — Phase 1 & 2
Human Immunodeficiency Virus Infection Research Study Groups: Low Dose CAR-T Cells Only, Conditioning + Low Dose CAR-T Cells, Conditioning + High Dose CAR-T Cells
Human Immunodeficiency Virus Infection Clinical Trial 2023: LVgp120duoCAR-T cells, high dose Highlights & Side Effects. Trial Name: NCT04648046 — Phase 1 & 2
LVgp120duoCAR-T cells, high dose (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04648046 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would this particular experiment be open to individuals who are octogenarians?

"The age bracket for patients that this trial is recruiting falls between 18-65 years old."

Answered by AI

To whom is this trial available?

"The current prerequisites for this study are that patients must have hiv infections and be between 18-65 years old. Right now, the trial is enrolling approximately 18 individuals."

Answered by AI

How many people are able to join this clinical trial?

"That is correct. The public information available on clinicaltrials.gov shows that this study has not yet reached its patient quota and is actively looking for test subjects. This trial was posted on March 1st, 2021 and updated May 17th, 2022. They are 18 patients remaining to be recruited between 2 hospitals."

Answered by AI

Are there any places open in this clinical trial for new participants?

"From what is detailed on clinicaltrials.gov, this particular trial is looking for more participants. The listing was first put up on 3/1/2021 and updated as recently as 5/17/2022."

Answered by AI

What type of cancer does LVgp120duoCAR-T cells, low dose usually help to improve?

"Multiple sclerosis, mixed-cell type lymphoma, and leukemia, myelocytic, acute can all be treated using low dose LVgp120duoCAR-T cells."

Answered by AI
~9 spots leftby Dec 2026