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

General Information

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".
Clinical trials phase Phase 1
Start date (estimated) 2024-07-15
End date (estimated) 2024-08-21
Clinical feature
Label human immunodeficiency virus infectious disease
Description A viral infectious disease that results in destruction of immune system, leading to life-threatening opportunistic infections and cancers, has_material_basis_in Human immunodeficiency virus 1 or has_material_basis_in Human immunodeficiency virus 2, which are transmitted by sexual contact, transmitted by transfer of blood, semen, vaginal fluid, pre-ejaculate, or breast milk, transmitted by congenital method, and transmitted by contaminated needles. The virus infects helper T cells (CD4+ T cells) which are directly or indirectly destroyed, macrophages, and dendritic cells. The infection has symptom diarrhea, has symptom fatigue, has symptom fever, has symptom vaginal yeast infection, has symptom headache, has symptom mouth sores, has symptom muscle aches, has symptom sore throat, and has symptom swollen lymph glands.

Administrative Information

NCT number NCT05700630
ICTRP weblink
Other study identifiers
Name 2022LS028
Source weblink
Public contact
Public email
First name Joshua
Last name Rhein
Phone +1 6126243898
City Minnesota
United States
Sponsors Masonic Cancer Center, University of Minnesota


Which differentiated cell type is used
Label natural killer cell
Description A lymphocyte that can spontaneously kill a variety of target cells without prior antigenic activation via germline encoded activation receptors and also regulate immune responses via cytokine release and direct contact with other cells.


Recruitment Status Withdrawn
Comment recruitment status Abandoned