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) (NCT04248192)
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (28 items) and avoid the listed exclusions (10 items).
Location: Johns Hopkins University(Jhu) — Baltimore, Maryland
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: Participant Exclusion Criteria DD HST-NEETs Infusion:
- Participants receiving ATG, or Campath or other immunosuppressive T-cell monoclonal antibodies within 28 days.
- Participants with uncontrolled infections. For bacterial infections, participants must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections participants must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection.
- Participants who have received donor lymphocyte infusion (DLI) within 28 days.
- Active and uncontrolled relapse of malignancy.
- Participants with active acute GVHD grades II-IV
- Participants with bronchiolitis obliterans syndrome or serositis
- Any licensed or experimental non-HIV vaccination (e.g., hepatitis B, pneumococcal polysaccharide) within 28 days prior to study entry.
- Inability to comply with study requirements, which could impact study integrity and/or safety. Donor Exclusion Criteria for Procurement for DD HST-NEETs Manufacturing:
- Donor exclusion criteria will be followed as per institution standard operating procedures (SOPs).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Johns Hopkins University(Jhu) — Baltimore, Maryland
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.