Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT05700630

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

MT2022-06: Phase I Study of FT538 Monotherapy and in Combination With Vorinostat for the Treatment of Persistent Low-Level HIV Viremia

Status
Withdrawn
Phase
Phase 1
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Masonic Cancer Center, University of Minnesota · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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".

Conditions

Interventions

TypeNameDescription
BIOLOGICALFT538FT538 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.
DRUGVorinostatVorinostat 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.

Timeline

Start date
2024-07-15
Primary completion
2024-07-26
Completion
2024-08-21
First posted
2023-01-26
Last updated
2024-02-26

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05700630. Inclusion in this directory is not an endorsement.