A Safety and Efficacy Trial of Chidamide Combined With NKG2D CAR-NK Cell Therapy for Reducing the… (NCT07577986) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Safety and Efficacy Trial of Chidamide Combined With NKG2D CAR-NK Cell Therapy for Reducing the HIV Viral Reservoir
China20 participantsStarted 2026-05-01
Plain-language summary
This study aims to investigate the safety and preliminary efficacy of an innovative therapeutic strategy combining chidamide with NKG2D-directed chimeric antigen receptor natural killer (CAR-NK) cells in individuals living with HIV. The approach is predicated on the "shock and kill" paradigm: chidamide is employed to reactivate latent HIV reservoirs and upregulate surface target ligands (NKG2D ligands) on infected cells; subsequently, allogeneic NKG2D CAR-NK cells are infused to specifically recognize and eliminate these "marked" cells.
This is a phase I, open-label, single-arm clinical trial comprising two distinct stages: a dose-escalation phase (phase Ia, utilizing a "1+3+3" design) and a dose-expansion phase (phase Ib). A total of 20 HIV-infected individuals who are stable on antiretroviral therapy (ART) and have suppressed plasma viremia are planned for enrollment. Participants will receive oral chidamide over approximately five weeks, followed by two cycles of intravenous CAR-NK cell infusion.
The primary endpoint is the safety and tolerability of the regimen, with particular attention to immune-related adverse events including cytokine release syndrome (CRS). Secondary endpoints encompass exploratory assessments of potential virologic and immunologic effects, such as alterations in plasma HIV RNA, cell-associated viral nucleic acids, and CD4+ T-cell counts. This study is intended to provide initial human safety data and preliminary evidence regarding the potential of this combination strategy to contribute toward a functional cure for HIV infection.
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
. Diagnosis of HIV infection, with a current history of highly active antiretroviral therapy (HAART) for a minimum duration of two years.
. Age between 18 and 65 years, inclusive.
. Plasma HIV RNA level \< 50 copies/mL (virologic suppression).
. CD4⁺ T cell count \> 200 cells/μL.
. Adequate hematologic function defined as:
. Adequate hepatic and renal function defined as:
. Hemodynamically stable with a left ventricular ejection fraction (LVEF) ≥ 45%.
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
Number of Participants with Study Drug-Related Adverse Events Grade 3 or Higher
Timeframe: From enrollment to the end of treatment at 24 weeks
2
Number of Participants with Study Drug-Related Immune-Related Adverse Events (IRAE)
Timeframe: From enrollment to the end of treatment at 24 weeks
3
Number of Participants with Adverse Events (AEs) Corresponding to Cytokine Release Syndrome
Timeframe: From enrollment to the end of treatment at 24 weeks
Trial details
NCT IDNCT07577986
SponsorFirst Affiliated Hospital of Zhejiang University
. Negative serum or urine pregnancy test for females of childbearing potential.
Exclusion criteria
. Presence of severe cardiovascular, respiratory, or hematologic disease; active infectious disease (other than controlled HIV infection); or active malignancy.
. Positive serology for hepatitis B surface antigen (HBsAg) or detectable hepatitis C virus RNA (HCV RNA).
. Diagnosis of chronic kidney disease (CKD).
. History or presence of acute or chronic pancreatitis.
. Active severe peptic ulcer disease.
. Current severe neurologic or psychiatric disorder.
. History of alcohol abuse or illicit substance use disorder.
. Known allergic diathesis or hypersensitivity to any component of the investigational agents.