CD4 CAR+ ZFN-modified T Cells in HIV Therapy

Hiv Clinical Trial

Official title: A Pilot Study of T Cells Genetically Modified by Zinc Finger Nucleases SB-728mR and CD4 Chimeric Antigen Receptor in HIV-infected Subjects

Status Active, not recruiting

Clinical Trial Summary

This research study is being carried out to study a new way to possibly treat HIV. As part of this study, doctors will take some of your own white blood cells, called T-cells, and modify them so that they can identify and target your HIV cells. The purpose of the study is to evaluate the safety of these modified T cells and determine whether they have any effect on HIV infection.

Clinical Trial Description

Step 1:

Subject is screened, undergoes leukaphereses, and optional rectal biopsy, and safety evaluations before dosing. The University of Pennsylvania manufactures the study product.

Step 2:

Subjects receive a single infusion of 0.5-1x10(10) CD4 CAR+CCR5 ZFN modified T cells. Cohort 2 participants undergo a mini-leukapheresis and optional rectal biopsy at the end of step 2.

The duration of Step 2 will be:

• Cohort 1: 1 day

• Cohort 2: 8 weeks

Step 3:

All subjects will participate in a 16 week analytical treatment interruption (ATI). ATI will be less than 16 weeks if patient's viral load is sustained >100,000 or CD4 count <350 or less than 50% of baseline. At the end of step 3 all participants will undergo mini-leukapheresis and optional rectal biopsy.

Step 4:

Participants who have HIV viral loads ≤1000 copies/ml will continue in an extension of the analytical treatment interruption until viral load is sustained >100,000 or CD4 count <350 or less than 50% of baseline.

Step 5:

Reinitiation of antiretroviral therapy with monthly visits until the HIV RNA is below the limit of quantification. All participants undergo a mini-leukapheresis and optional rectal biopsy at the end of the step 5.

Step 6 (Secondary Follow-up):

All subjects will be followed for safety for up to 5 years post-infusion. ;

Related Conditions & MeSH terms

• Hiv

• NCT number: NCT03617198
• Study type: Interventional
• Source: University of Pennsylvania
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 31, 2019
• Completion date: December 2027