NCT04248192

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)

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)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Catherine Bollard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The primary objective of this study is to evaluate the safety of donor-derived allogeneic expanded HIV-specific T-cell therapy (DD HST-NEETs) in HIV-infected alloBMT recipients on ART. 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.

Conditions

• HIV-Infected Individuals

Interventions

Type	Name	Description
BIOLOGICAL	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.

Timeline

• Start date: 2020-05-01
• Primary completion: 2025-09-01
• Completion: 2026-04-01
• First posted: 2020-01-30
• Last updated: 2025-04-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study