Ignite Creation Date:
2024-05-06 @ 2:05 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04201782
Status:
TERMINATED
Last Update Posted:
2024-01-26
First Post:
2019-12-13
Brief Title:
Long-term Follow-up of HIV Subjects Exposed to SB-728-T or SB-728mR-T
Sponsor:
Sangamo Therapeutics
Organization:
Sangamo Therapeutics
Study Overview
Official Title:
Long-Term Follow-up of HIV-Infected Subjects Treated With Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728-T or SB-728mR-T
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
There have been no significant safety issues in any subjects exposed between 75 and 135 years ago to either SB-728-T or SB-728mR-T including no delayed adverse events related to the investigational product
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T Enrolling subjects will be followed for a total of 12 years
Detailed Description:
Subjects infected with HIV who have received therapy with SB-728-T or SB-728mR-T will be eligible to participate in this trial There will be no treatment in this long-term follow-up study Subjects who choose to enroll into this extension study will be evaluated for a total of 12 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None