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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
-SB-728mR-T infusions of 2 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
\- SB-728mR-T infusions of 3 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
\- IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
Unnamed facility
San Francisco, California, United States
Unnamed facility
Norwalk, Connecticut, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Austin, Texas, United States
Unnamed facility
Primary Outcome Measure
Number of Participants with Treatment related Adverse Events in subjects who received any portion of the SB-728mR-T infusion
Time frame: 12 months
Secondary Outcome Measure
Effect of repeat doses of SB-728mR-T on engraftment following cyclophosphamide conditioning as measured by CCR5 Modified CD4 Cells at Month 12.
Time frame: 12 months
Secondary Outcome Measure
Effect of SB-728mR-T on plasma HIV-1 RNA levels following HAART interruption
Time frame: 12 months
Secondary Outcome Measure
Change from baseline to month 12 in CD4+ T-cell counts in peripheral blood after repeat treatments with SB-728mR-T. (i.e. month 12 value - baseline value)
Time frame: Baseline and 12 months
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Dallas, Texas, United States