This phase I trial investigates the safety, immune and virus responses of human immunodeficiency virus (HIV)-specific T-cell therapy (donor derived HIV-specific T-cells with non-escaped epitope targeting [DD HST-NEETs]) in HIV-infected individuals managing on anti-HIV medicines (antiretroviral therapy) following allogeneic (donor) bone marrow transplant. Allogeneic transplant in patients with HIV-1 infection presents some special risks and special opportunities. Donor T cells targeting HIV-1 may help protect the new donor bone marrow and immune system from HIV-1 infection.
Additional locations may be listed on ClinicalTrials.gov for NCT04248192.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To evaluate the safety of the administration of donor derived (allogeneic) ex vivo expanded human immunodeficiency virus (HIV)-1 antigen specific T-cell (DD HST-NEETs) therapy in HIV-infected individuals on antiretroviral therapy (ART) following allogeneic (allo) bone marrow transplant (BMT).
SECONDARY OBJECTIVES:
I. To determine the feasibility of manufacturing of DD HST-NEETs.
II. To summarize the in vivo measurements of HIV-specific T-cells over the pre- to post-infusion period to assess the pattern and magnitude of DD HST-NEETs expansion and persistence in vivo.
III. To summarize the HIV reservoir measurements over the pre-BMT, pre-DD HST-NEETs infusion, post-infusion period to assess any change in the HIV reservoir following infusion.
OUTLINE:
Patients receive DD HST-NEETs intravenously (IV) on day 0.
After completion of study treatment, patients are followed up within 2 to 3 days post-infusion, then on days 7, 14, 21, 28, 35, 45, 56, 90, 180 and 365.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorRichard F. Ambinder
