Overview

This trial is active, not recruiting.

Condition human immunodeficiency virus (hiv)
Treatments sb-728mr-t, cyclophosphamide
Phase phase 1/phase 2
Sponsor Sangamo Biosciences
Start date August 2014
End date March 2018
Trial size 12 participants
Trial identifier NCT02225665, SB-728mR-1401

Summary

The purpose of this study is to evaluate the safety and tolerability of repeat doses of T-cell immunotherapy (SB-728mR-T) following cyclophosphamide conditioning.

CCR5 is a major co-receptor for HIV entry into T-cells. Disruption of CCR5 by zinc finger nuclease (SB-728mR), blocks HIV entry into the T-cells, therefore, protects the T-cells from HIV infection. Safety (primary outcome) and anti-viral effect (secondary outcome) of zinc finger nuclease-mediated CCR5 disrupted autologous T-cells (SB-728mR-T) will be evaluated in the study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
sb-728mr-t
-SB-728mR-T infusions of 2 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
cyclophosphamide
- IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
(Experimental)
sb-728mr-t
- SB-728mR-T infusions of 3 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
cyclophosphamide
- IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion

Primary Outcomes

Measure
Primary Outcome Measure
time frame: 12 months

Secondary Outcomes

Measure
Secondary Outcome Measure
time frame: 12 months
Secondary Outcome Measure
time frame: 12 months
Secondary Outcome Measure
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Male or female, 18 years of age or older with documented HIV diagnosis. - Must be willing to comply with study-mandated evaluations; including discontinuation of current antiretroviral therapy during the treatment interruption. - Initiated HAART therapy within (≤) 1 year of HIV diagnosis or suspected infection. - Undetectable HIV-1 RNA for at least 2 months prior to screening and at screening. - CD4+ T-cell count ≥500 cells/µL. - Absolute neutrophil count (ANC) ≥ 2500/mm3. - Platelet count ≥ 200,000/mm3. Exclusion Criteria: - Acute or chronic hepatitis B or hepatitis C infection. - Active or recent (in prior 6 months) AIDS defining complication. - Any cancer or malignancy within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin or low grade (0 or 1) anal or cervical dysplasia. - Current diagnosis of NYHA grade 3 or 4 CHF, uncontrolled angina or uncontrolled arrhythmias. - History or any features on physical examination indicative of a bleeding diathesis. - Received HIV experimental vaccine within 6 months prior to screening, or any previous gene therapy using an integrating vector. - Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents within 30 days prior to screening. - Use of Aspirin, dipyridamole, warfarin or any other medication that is likely to affect platelet function or other aspects of blood coagulation during the 2 week period prior to leukapheresis. - Currently participating in another clinical trial or participation in such a trial within 30 days prior to screening visit. - Currently taking maraviroc or have received maraviroc within 6 months prior to screening.

Additional Information

Official title A Phase 1/2, Open-Label Study to Assess the Safety and Tolerability of Repeat Doses of Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Subjects Following Cyclophosphamide Conditioning
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Sangamo Biosciences.