NCT03485963

HIV-1 Specific T -Cells (HST-NEETs) for HIV-Infected Individuals

A Phase I Study to Evaluate the Safety, Immunologic, and Virologic RESponses of HIV-Specific T-cells With Non-escaped Epitope Targeting (HST-NEETs) as a Therapeutic Strategy in HIV-Infected Individuals on Antiretroviral Therapy During Acute And Chronic Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Catherine Bollard · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I, multi-site, study of the safety, immunologic and virologic responses of ex vivo expanded HIV-1 multi-antigen specific T-cell therapy (HST-NEET) as a therapeutic strategy in HIV-infected individuals suppressed on antiretroviral therapy (ART).

Detailed description

Treatment Description: This is a phase I, multi-site, study of the safety, immunologic and virologic responses of ex vivo expanded HIV-1 multi-antigen specific T-cell therapy (HST-NEET) as a therapeutic strategy in HIV-infected individuals suppressed on ART. Patients will be screened for eligibility in Step 1 and undergo a blood draw of 100-120mL to allow production of autologous HST-NEETS. Those meeting study eligibility and with successful production of HST-NEETs will then enter Step 2 where patients have the OPTION of being enrolled on a separate GWU Protocol 04216 to obtain a pre- and post- HST-NEET treatment leukapheresis procedure to measure the frequency of HIV-1 infection of resting CD4+ T cells using the viral outgrowth assay. All participants will then receive (within 30 days of the leukapheresis procedure if applicable) the same treatment and dose (2x107/m2) of HST-NEETs in Step 2. For the first 3 recipients, the infusions will occur 4 weeks apart. If no adverse reactions occur that are attributable to the HST-NEETs, the recipients thereafter will receive the two infusions separated by 2 weeks. Sample Size and Study Duration: Up to 12 HIV-infected individuals followed for 48 weeks. Accrual Objective: The total sample size is 12 participants. Participants will be followed for 48 weeks. Because the focus of the study is on safety and potential adverse events are most likely to occur within 28 days of administration, accrual will be staggered such that enrollment and treatment administration will include a maximum of 1 participant per week. Participants who do not receive study treatment will be replaced. In addition, any participant who is not administered the full study treatment infusion, or discontinues the study prior to day 28 without having met the primary safety endpoint will be replaced until the target enrollment of participants is met.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	HST-NEETs	The primary objective of this study is to evaluate the safety and tolerability of expanded HIV-specific T cell therapy (HST-NEETs) in HIV-infected individuals suppressed on cART. Patients with a partial response or stable disease 8 weeks after T-cell infusion were eligible to receive additional T-cells, consisting of the same number of cells as their second injection.

Timeline

• Start date: 2019-03-21
• Primary completion: 2021-09-15
• Completion: 2022-06-21
• First posted: 2018-04-03
• Last updated: 2025-04-29

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study