Ph1 Study of FT538 Alone and With Vorinostat for Persistent Low-Level HIV Viremia (NCT05700630) | Clinical Trial Compass
WithdrawnPhase 1
Ph1 Study of FT538 Alone and With Vorinostat for Persistent Low-Level HIV Viremia
Stopped: Abandoned
United States0Started 2024-07-15
Plain-language 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".
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Male or female, age ≥18 and ≤65 years at the time of signing the consent form
* HIV-1 infection on continuous antiretroviral therapy (ART) for at least 12 months without any interruptions of greater than 14 consecutive days and without plans to modify ART before the End of Treatment visit.
* Two or more consecutive detectable HIV RNA levels of ≤200 copies/mL in the last 2 years, with at least one determination meeting this criterion in the previous 12 months. (If testing was not obtained within 42 days of planned dose 1, test will be repeated during subject screening to confirm status)
* Screening CD4+ T cell count ≥350 cells/ µl within 28 days of the 1st dose of FT538.
* Completion of initial COVID-19 vaccination series and/or documented COVID-19 infection with completion of treatment ≥ 3 months prior
* Patient weight of ≥ 50 kg due to FT538 fixed cell dosing and FT538 product pre-dosed packaging.
Adequate organ function within 14 days of Day 1, defined as the following:
* Platelet counts \>150,000/mm\^3
* Hemoglobin \> 12.5 g/dL for men and \> 11.5 g/dL for women. It is not acceptable for patients to be transfused within the prior month to meet this requirement. The use of Epogen is permitted.
* AST and ALT ≤ 3 x upper limit of institutional normal
* Estimated CrCl (eGFR) \>50 mL/min/1.73m\^2
* Persons of childbearing potential or with partners of childbearing potential must be willing to abstain from heterosexual activity or to use a highly effecti…
What they're measuring
1
Determine the safety and feasibility of administering FT538 monotherapy.
Timeframe: 26 months
Trial details
NCT IDNCT05700630
SponsorMasonic Cancer Center, University of Minnesota