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CAR T-cell Therapy

HST-NEETs for HIV (RESIST Trial)

Phase 1

Waitlist Available

Led By Michael Keller, MD

Research Sponsored by Catherine Bollard

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky score of ≥ 50%

≥ 18 years and < 65 years of age

Must not have

Patients on a CCR5 inhibitor or an entry inhibitor are not eligible for participation in the study

Any active malignancy that may require chemotherapy or radiation therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new HIV treatment that uses the body's own T-cells. The aim is to see if it is safe and if it can help people with HIV who are already on treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

As this is an early-phase trial primarily assessing safety of HST-NEETs cell therapy in humans, specific side effects aren't listed but may include typical reactions related to immune therapies such as infusion-related symptoms or autoimmune-like conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to live with some assistance.

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I am between 18 and 64 years old.

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I have good veins for receiving infusion treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking CCR5 or entry inhibitors.

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I have a cancer that needs chemotherapy or radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Product-Emergent Adverse Events

Secondary study objectives

HST-NEETS responses

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 5Eligibility criteria met