Ignite Creation Date:
2024-05-06 @ 3:11 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02225665
Status:
COMPLETED
Last Update Posted:
2021-03-19
First Post:
2014-08-22
Brief Title:
Repeat Doses of SB-728mR-T After Cyclophosphamide Conditioning in HIV-Infected Subjects on HAART
Sponsor:
Sangamo Therapeutics
Organization:
Sangamo Therapeutics
Study Overview
Official Title:
A Phase 12 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
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None