Modified T Cells for HIV Therapy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new approach to treat HIV by using participants' own T cells, a type of white blood cell, to better target the virus. The goal is to determine if these modified T cells, specifically CD4 CAR+CCR5 ZFN T-cells, are safe and can effectively reduce HIV infection. Participants will receive the modified cells and then pause their regular HIV treatment for a period to test the results. This trial may suit individuals who have been stable on HIV medication with a low viral load and are open to trying a new treatment method. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot be taking a non-nucleoside reverse transcriptase inhibitor (NNRTI) or certain medications affecting blood clotting before the procedure. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that a new HIV treatment involving modified T-cells has generally been safe in earlier studies. These studies involved altering a person's own T-cells (a type of white blood cell) to combat HIV. For instance, one study found that these modified T-cells were well-tolerated, with participants experiencing no serious side effects. Another study confirmed the safety of using these gene-edited T-cells, as they did not cause major issues. These findings suggest the treatment is likely safe for participants, though it remains in the early stages of testing.12345
Why do researchers think this study treatment might be promising?
Most treatments for HIV work by suppressing the virus with daily antiretroviral medications. But the investigational therapy using CD4 CAR+CCR5 ZFN T-cells is different, as it aims to modify the body's own immune cells to resist HIV infection. This approach involves reprogramming T-cells to directly target and eliminate HIV-infected cells, offering a potential one-time intervention that could reduce or eliminate the need for lifelong medication. Researchers are excited because this method not only targets the virus more precisely but also represents a novel approach that could lead to long-term remission or even a functional cure.
What evidence suggests that CD4 CAR+CCR5 ZFN T-cells might be an effective treatment for HIV?
Research shows that a new type of modified T-cells, known as CD4 CAR+CCR5 ZFN T-cells, could help treat HIV. These T-cells have been altered to enhance the body's ability to combat the virus. In earlier studies, these modified T-cells resisted HIV infection, both in the lab and in early human trials. Approximately 8.8% of these T-cells were successfully modified, suggesting they might help reduce the virus in the body. Although these results are preliminary, they offer hope for improved HIV treatment in the future. Participants in this trial will receive these modified T-cells, with Cohort 1 beginning treatment interruption about 24 hours after receiving the T-cells, and Cohort 2 beginning treatment interruption about 8 weeks later.12346
Who Is on the Research Team?
Pablo Tebas, MD
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
This trial is for adults over 18 with HIV who've had a stable viral load (≤50 copies/mL) for at least 24 weeks, are on their first or second antiretroviral therapy, and have certain levels of T cells. They must not have hepatitis B/C, AIDS, cancer history (except some skin cancers), heart disease without approval, bleeding disorders, recent gene therapy or experimental vaccines for HIV.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Subjects receive a single infusion of CD4 CAR+CCR5 ZFN modified T cells
Analytical Treatment Interruption (ATI)
Participants undergo a 16-week ATI, with monitoring of viral load and CD4 count
Extension of ATI
Participants with viral loads ≤1000 copies/ml continue ATI until specific criteria are met
Reinitiation of Antiretroviral Therapy
Participants restart antiretroviral therapy with monthly visits until HIV RNA is below quantification limit
Secondary Follow-up
All subjects are followed for safety for up to 5 years post-infusion
What Are the Treatments Tested in This Trial?
Interventions
- CD4 CAR+CCR5 ZFN T-cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor