Repeat Doses of SB-728mR-T After Cyclophosphamide Conditioning in HIV-Infected Subjects on HAART

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sangamo Biosciences; Sangamo Therapeutics
• Treatments: Cyclophosphamide

Criteria

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.