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RECRUITING
NCT04648046
PHASE1/PHASE2

CAR-T Cells for HIV Infection

Sponsor: Steven Deeks

View on ClinicalTrials.gov

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.

Official title: Safety and Anti-HIV Activity of Autologous CD4+ and CD8+ T Cells Transduced With a Lentiviral Vector Encoding Bi-specific Anti-gp120 CAR Molecules (LVgp120duoCAR-T) in Anti-retroviral Drug-treated HIV-1 Infection

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2021-03-01

Completion Date

2029-12-31

Last Updated

2026-04-09

Healthy Volunteers

No

Conditions

Interventions

DRUG

Cyclophosphamide

Non-ablative conditioning with cyclophosphamide.

BIOLOGICAL

LVgp120duoCAR-T cells, low dose

A single dose of 3 x 10\^5 cells/kg LVgp120duoCAR-T cells will be infused.

BIOLOGICAL

LVgp120duoCAR-T cells, high dose

A single dose of 1 x 10\^6 cells/kg LVgp120duoCAR-T cells will be infused.

OTHER

Analytic Treatment Interruption

HIV antiretroviral therapy medications will be paused.

Locations (2)

University of California, Davis

Sacramento, California, United States

Zuckerberg San Francisco General

San Francisco, California, United States