Sangamo
SB-728
A
Phase I Study of Autologous T-Cells Genetically Modified
by Zinc Finger Nucleases SB-728 for Reduced CCR5 Expression
in HIV-Infected Patients with Detectable Plasma HIV
RNA who have Developed Resistance to Highly Active
Anti-Retroviral Therapy (HAART).
Purpose
of this Study:
To test the following hypothesis: Autologous CD4+
T cells genetically modified at CCR5 gene by Zinc
Finger Nucleases SB-728 will be safe and tolerable
in HIV-1 positive subjects.
Requirements to Enter Study:
- Cohort
1:
RNA levels .2000 copies/mL and <150,000 copies/mL
and CD4+ T cell counts .200 cells/mm3, who have
been on two or more HAART regimens and have failed
due to resistance or tolerance. Patients must be
CCR5 tropic.
- Cohort
2: RNA levels <50 copies/ml and CD4+ T cells
counts .450 cells/mm3; and a documented CD4 nadir
of not lower than 300 cells/mm, and who have a recorded
viral load set point prior to starting therapy.
Treatment: Autologous CD4 T cells genetically
modified at CCR5 gene with zinc finger nucleases SB-728.
Length of Study:
Cohort 1: Approximately 1 year from screening
visit.
Cohort 2: Approximately 40 weeks from screening
visit.
For
more information contact:
Study
Contacts
Larisa
Zifchack , RN (215) 349-8092
