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CAR T-cell Therapy
FT538 + Vorinostat for HIV
Phase 1
Waitlist Available
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female, age ≥18 and ≤65 years at the time of signing the consent form
Patient weight of ≥ 50 kg due to FT538 fixed cell dosing and FT538 product pre-dosed packaging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights
Study Summary
This trial tests a new drug to reduce HIV reservoirs in people receiving standard treatment. It's the 1st study of its kind. Safety is confirmed first.
Who is the study for?
Adults aged 18-65 with HIV on stable antiretroviral therapy, weighing at least 50 kg, and having adequate organ function can join. They must have a recent CD4+ count ≥350 cells/µl and low-level HIV viremia. Participants need to agree to long-term follow-up and use effective contraception if of childbearing potential.Check my eligibility
What is being tested?
The trial is testing FT538, an intravenous treatment given every two weeks for four doses, aimed at reducing the HIV reservoir in lymphoid tissue. For some patients, Vorinostat will be added later to test the 'Kick and Kill' strategy against persistent HIV infection.See study design
What are the potential side effects?
As this is a first-in-human study for FT538 in people with HIV, specific side effects are not yet known but may include typical reactions related to immune cell infusions such as fever or fatigue. Vorinostat can cause gastrointestinal symptoms like nausea or diarrhea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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I weigh at least 50 kg.
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My organs are functioning well, as tested within the last two weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the safety and feasibility of administering FT538 monotherapy.
Secondary outcome measures
Characterize the toxicities associated with FT538 monotherapy and vorinostat.
Determine the impact of FT538 on the persistence of low-level HIV viremia
Other outcome measures
Characterize FT538 and Vorinostat Relationship with HIV RNA
FT538 impact on frequency and phenotype of viral cells in PBMC lymphocyte subsets.
Optional lymphoid tissue collection
Trial Design
2Treatment groups
Experimental Treatment
Group I: Determine the safety and feasibility of administering FT538 monotherapyExperimental Treatment1 Intervention
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.
Group II: Characterize the toxicities and impact of FT538 and vorinostatExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vorinostat
2014
Completed Phase 3
~1600
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
271 Previous Clinical Trials
14,625 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a stroke, epilepsy, or similar brain conditions in the last 2 years.I have had heart or blood vessel problems in the last year.I have completed treatment for TB, confirmed by tests.I am not pregnant or breastfeeding and agree to use birth control for 4 months after my last dose.I am not on or likely to need strong immune system suppressing drugs around the time I would take FT538.I haven't had or don't need major cancer treatment in the last 3 years, except for minor skin cancer surgeries.I haven't taken any experimental drugs not approved by the FDA in the last 28 days.My liver disease is moderate to severe according to the Child-Pugh scale.I have not had an infection treated in the last 3 months.I am currently on medication for a serious fungal infection.I have chronic active hepatitis B or C.I haven't had any vaccines in the 6 weeks before starting FT538.I am between 18 and 65 years old.I have been on HIV medication for over a year without any breaks longer than two weeks.I weigh at least 50 kg.My organs are functioning well, as tested within the last two weeks.I've completed my initial COVID-19 vaccination or recovered from COVID-19 over 3 months ago.My hemoglobin level is above the required threshold without recent transfusions.I will use effective birth control during and for 6 months after the study.I am a male and will use effective birth control during and up to 4 months after the study.You have a history of alcohol or drug abuse that may affect your ability to participate in the study or could put you at higher risk.I am considering the treatment combination of FT538 and Vorinostat.I have moderate to severe lung disease or my lung function test shows less than 80% of what's expected.I have tested positive for COVID-19 recently or had it in the last 3 months.I have had a solid organ or bone marrow transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Determine the safety and feasibility of administering FT538 monotherapy
- Group 2: Characterize the toxicities and impact of FT538 and vorinostat
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are persons aged under thirty admissible for this research?
"The patient selection criteria indicate that the lower age limit is 18 and the maximum age requirement is 65."
Answered by AI
To whom does this research opportunity extend?
"To participate in this medical experiment, individuals must have interleukins and be within the specified age group of 18 to 65. Approximately 34 patients are required for enrollment."
Answered by AI
To what extent can FT538 monotherapy be regarded as a safe and viable option for individuals?
"Due to the paucity of evidence surrounding Determine the safety and feasibility of administering FT538 monotherapy, our Power team assessed its safety as a 1 on their 3-point scale."
Answered by AI
Are there any opportunities to take part in this clinical experiment at present?
"Data from clinicaltrials.gov reveals that this particular medical trial is not presently seeking patients; its first post date was January 15th 2023 and the last update was on January 17th 2023. However, 859 other studies are actively recruiting right now."
Answered by AI
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