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CAR-T Cells for HIV Infection

NCT04648046 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-04-09

No results posted yet for this 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

  • HIV Infections

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.

Sponsors & Collaborators

  • Caring Cross

    collaborator UNKNOWN

  • Steven Deeks

    lead OTHER

Principal Investigators

  • Steven Deeks, MD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04648046 on ClinicalTrials.gov