Donor-Derived T-cell Therapy for HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a multi-site phase 1 study of the safety, immunologic and virologic responses of ex vivo expanded donor-derived (DD) HIV-1 multi-antigen specific T-cell (HST) with non-escaped epitope targeting (NEET) therapy as a therapeutic strategy in HIV-infected individuals following Allogeneic Bone Marrow Transplantation (alloBMT).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must continue your antiretroviral therapy throughout the study.
Is donor-derived T-cell therapy for HIV safe for humans?
How is the Donor-Derived T-cell Therapy for HIV different from other treatments?
This treatment is unique because it uses donor-derived T-cells specifically designed to target multiple parts of the HIV virus, potentially preventing the virus from rebounding after stem cell transplants. Unlike traditional treatments that rely on antiretroviral drugs, this therapy aims to provide long-lasting HIV-specific immunity by eliminating newly infected cells before they can spread.46789
What data supports the effectiveness of the treatment Donor-Derived T-cell Therapy for HIV?
Research shows that donor-derived virus-specific T cells (VSTs) can effectively restore virus-specific immunity and control viral infections after stem cell transplants, with response rates of 60% to 90% in recipients. Additionally, HIV-specific T cells generated from naive T cells have been shown to suppress active HIV in laboratory settings, suggesting potential for this treatment in managing HIV.478910
Who Is on the Research Team?
Richard Ambinder, MD, PhD
Principal Investigator
Johns Hopkins University
Michael Keller, MD
Principal Investigator
CNMC
Are You a Good Fit for This Trial?
This trial is for HIV-infected adults who've had an allogeneic bone marrow transplant. They must be on effective antiretroviral therapy, have good organ function, no active hepatitis C or B, and a Karnofsky score of ≥ 70. Pregnant women can't participate, and participants need to agree to study requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DD HST-NEETs at a dose of 2x107/m2 within 30 days of screening visit
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for long-term safety and virologic responses
What Are the Treatments Tested in This Trial?
Interventions
- DD HST-NEETs
Find a Clinic Near You
Who Is Running the Clinical Trial?
Catherine Bollard
Lead Sponsor