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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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