CAR-T Cells for HIV Infection

Part of paid clinical trials in Sacramento, California.

Sponsor
Steven Deeks
Study ID
NCT04648046
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Non-ablative conditioning with cyclophosphamide.
  • LVgp120duoCAR-T cells, low dose — BIOLOGICAL
    A single dose of 3 x 10\^5 cells/kg LVgp120duoCAR-T cells will be infused.
  • LVgp120duoCAR-T cells, high dose — BIOLOGICAL
    A single dose of 1 x 10\^6 cells/kg LVgp120duoCAR-T cells will be infused.
  • Analytic Treatment Interruption — OTHER
    HIV antiretroviral therapy medications will be paused.

Study Details

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.

Key Dates

Start date
Mar 1, 2021
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Low Dose CAR-T Cells Only
    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.
  • Experimental: Conditioning + Low Dose CAR-T Cells
    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.
  • Experimental: Conditioning + High Dose CAR-T Cells
    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.

Primary Outcome Measure

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. [ Time Frame: Within 1 year of product administration ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, DavisSacramentoCalifornia95817
Christina Dyner, RN
[email protected]
Mehrdad Abedi (PRINCIPAL_INVESTIGATOR)
Zuckerberg San Francisco GeneralSan FranciscoCalifornia94110
Rebecca Hoh, MS
[email protected]
415-476-4082
Steven Deeks, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sacramento, CA

By condition
HIV
By specialty
Infectious disease
By research site
University of California, Davis· Sacramento, CAZuckerberg San Francisco General· San Francisco, CA

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