HST-NEETs for HIV
(RESIST Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byMichael Keller, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Catherine Bollard

No Placebo Group

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

This trial is for HIV-infected adults aged 18-65 with undetectable viral loads on ART for at least a year, CD4+ counts over 350, and no active hepatitis. Participants must be willing to continue ART, use contraception, and have good vascular access. Excluded are those with recent cancer treatments or immunotherapies, certain medication use within the last 90 days, or any condition that may interfere with the study.

Inclusion Criteria

Ability and willingness to provide adequate locator information and contact information for at least 2 adults who can reach the participant within 24 hours

Recipient Inclusion Criteria for cell procurement and cell infusion:

Confirmation of HIV-1 infection

+16 more

Exclusion Criteria

I haven't taken any immune-modifying drugs or certain blood thinners in the last 90 days.

I have not received blood products or immune treatments in the last 3 months.

Inability to comply with study requirements, which could impact study integrity and/or safety.

+5 more

Participant Groups

The trial tests HST-NEETs (HIV-specific T-cells) in individuals who are HIV-positive but have controlled the virus using antiretroviral therapy (ART). It's a phase I study focusing on safety and how well these cells can boost immune response against HIV.

1Treatment groups

Experimental Treatment

Group I: Fixed dose HIV-1 specific T-cells (HST-NEETs)Experimental Treatment1 Intervention

Patients will be screened for eligibility in Step 1 and undergo a blood draw of 100-120mL to allow production of autologous HST-NEETS. patients will receive a fixed dose of 2x10e7/m2. 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.