HIV-1 study: CMV/HIV-CAR T Cells
Official title CMV-specific HIV-CAR T Cells as Immunotherapy for HIV/AIDS
ClinicalTrials.gov ID: NCT06252402
What this study is testing
What is CMV/HIV-CAR T Cells?
An investigational cellular therapy being studied as a potential treatment for HIV-1 infection. It is designed to be T cells engineered with a chimeric antigen receptor that recognizes the HIV‑1 envelope protein gp120 and also includes CMV‑specific features to help the cells persist in the body.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether giving people HIV‑CAR T cells made from their own CMV‑specific T cells can stay in the body longer and help control HIV while they keep taking ART.
- Who it's for
- You may be able to join if you are a person living with HIV‑1, on stable ART, and have a CMV infection.
- What's involved
- You will receive a blood draw to collect your T cells, which are then engineered in a lab to target HIV. After the cells are ready, you will get an infusion of the new cells. You will have follow‑up visits for blood tests and safety checks.
- Time commitment
- The study lasts about 12 months, with an infusion visit and several follow‑up visits over that time.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Participant must be ≥ 18 years of age at the time of screening;
- Karnofsky Performance Status (KPS) ≥ 70;
- Documented HIV-1 infection anytime prior to study entry.;
- On stable ART with undetectable HIV-1 RNA (i.e \< 20 copies /mL) for at least 48 weeks prior to screening (2 plasma HIV-1 RNA blips 25-200 copies/mL...
- CD4+ cell count ≥ 450 cells/μL;
You likely can't join if
- Concurrent illness or comorbid condition;
- History of resistance to two or more classes of antiretroviral drugs;
- History of prior receipt of an experimental HIV-1, immunotherapeutic agent, or gene therapy product.
See the full eligibility criteria
- Participant must be ≥ 18 years of age at the time of screening;
- Karnofsky Performance Status (KPS) ≥ 70;
- Documented HIV-1 infection anytime prior to study entry.;
- On stable ART with undetectable HIV-1 RNA (i.e \< 20 copies /mL) for at least 48 weeks prior to screening (2 plasma HIV-1 RNA blips 25-200 copies/mL are allowable);
- CD4+ cell count ≥ 450 cells/μL;
- Adequate organ function;
- Willingness to interrupt ART regimen for 4 days prior to leukapheresis;
- Not pregnant or breastfeeding.
- Concurrent illness or comorbid condition;
- History of resistance to two or more classes of antiretroviral drugs;
- History of prior receipt of an experimental HIV-1, immunotherapeutic agent, or gene therapy product.
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- San Diego, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; San Diego, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.