← Back to Search

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

Must not have

Chronic liver disease

Any history of an HIV-associated malignancy, including Kaposi's sarcoma and any type of lymphoma, or virus-associated cancers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 1 year of product administration

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

I've been on stable HIV treatment for over a year without breaks longer than 2 weeks.

Select...

I am infected with HIV-1.

Select...

I am willing to stop my current HIV treatment for the study.

Select...

I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a long-term liver condition.

Select...

I have had a cancer linked to HIV, like Kaposi's sarcoma or lymphoma.

Select...

I have a current or past infection of hepatitis B.

Select...

I have tuberculosis.

Select...

I have an active hepatitis C infection.

Select...

I have heart disease that is not well-managed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1 year of product administration

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2010

Completed Phase 4

~2310

0 / 10Eligibility criteria met