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Evaluate the Safety, Immunologic, and Virologic Responses of Donor Derived (DD) HIV-Specific T-cells (HST) in HIV-infected Individuals Following Allogeneic Bone Marrow Transplantation (alloRESIST)
Sponsor: Catherine Bollard
Summary
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).
Official title: A Study to Evaluate the Safety, Immunologic, and Virologic RESponses of Donor Derived (DD) HIV-Specific T-cells (HST) With Non-escaped Epitope Targeting (NEETs) in HIV-Infected Individuals on Antiretroviral Therapy Following Allogeneic Bone Marrow Transplantation (alloRESIST)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
8
Start Date
2020-05-01
Completion Date
2026-04
Last Updated
2025-04-29
Healthy Volunteers
No
Conditions
Interventions
DD HST-NEETs
HIV-infected individuals following Allogeneic Bone Marrow Transplantation (alloBMT) will be treated with DD HST-NEETS therapy. Participants and donors will be screened for eligibility. Eligible donors will undergo a blood draw of up to 300mL to allow production of allogeneic DD HST-NEETs. Participants, who meet specified inclusion criteria including neutrophil recovery post-transplant and for whom donor products have passed release testing, will receive DD HST-NEETs at a dose of 2x107/m2 within 30 days of screening visit.
Locations (1)
Johns Hopkins University(Jhu)
Baltimore, Maryland, United States