Ph1 Study of FT538 Alone and With Vorinostat for Persistent Low-Level HIV Viremia

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT05700630
Phase
PHASE1
Status
Withdrawn

Conditions

  • ART
  • Cd4+ Lymphocyte Deficiency
  • HIV-1-infection
  • Interleukin
  • Lymphoid Tissue; Infection

Eligibility Criteria

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

Interventions

  • FT538 — BIOLOGICAL
    FT538 is an investigational off-the-shelf cryopreserved NK cell product derived from an iPSC that contains three functional modifications: 1) a novel high affinity, non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface and remains fully functional after NK cell activation, thus augmenting ADCC; 2) an IL-15 receptor fusion that promotes NK cell activity and enhances cell persistence; and 3) the knock-out of CD38 expression prevent anti-CD38 antibody-induced fratricide.
  • Vorinostat — DRUG
    Vorinostat is a histone deacetylase inhibitor (HDACi) that is FDA approved for the treatment of cutaneous T-cell lymphoma and, under investigation in HIV as disruptor of HIV latency.

Study Details

This is a single center Phase I clinical trial of FT538 administered intravenously (IV) once every 14 days for 4 consecutive doses for the reduction of the HIV reservoir in lymphoid tissue of HIV-infected individuals receiving standard of care (SOC) antiretroviral therapy (ART). As this is an early 1st in human study and the 1st for HIV-infected individual, the safety of FT538 is confirmed prior to the addition of oral vorinostat to explore the concept of "Kick and Kill".

Key Dates

Start date
Jul 15, 2024
Status verified
Feb 2024
Primary completion
Jul 26, 2024
Completion
Aug 21, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Determine the safety and feasibility of administering FT538 monotherapy
    Administering FT538 monotherapy as an intravenous infusion once every 14 days for 4 consecutive doses and in combination with twice weekly vorinostat for the reduction of the HIV reservoir.
  • Experimental: Characterize the toxicities and impact of FT538 and vorinostat
    To characterize the toxicities associated with FT538 monotherapy and with vorinostat in this patient population. To determine the impact of FT538 on the persistence of low-level HIV viremia, defined as detectable HIV-1 RNA of ≤200 copies/mL despite good ART adherence.

Primary Outcome Measure

Determine the safety and feasibility of administering FT538 monotherapy. [ Time Frame: 26 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Masonic Cancer Center at University of MinnesotaMinneapolisMinnesota55455-

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Masonic Cancer Center at University of Minnesota· Minneapolis, MN

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