Ignite Creation Date:
2024-05-06 @ 7:17 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02500849
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2015-03-16
Brief Title:
Safety Study of Zinc Finger Nuclease CCR5-modified Hematopoietic Stemprogenitor Cells in HIV-1 Infected Patients
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
A Pilot Study to Evaluate the Feasibility Safety and Engraftment of Zinc Finger Nuclease ZFN CCR5 Modified CD34 Hematopoietic StemProgenitor Cells SB-728mR-HSPC in HIV-1 R5 Infected Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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 the study is to evaluate the safety and feasibility of administering SB-728mR-HSPC after conditioning with busulfan
Detailed Description:
The objective of the study is to evaluate the safety and feasibility of giving autologous SB-728mR-HSPC to HIV-1 R5 infected patients who are being treated with cART and have undetectable virus but suboptimal CD4 cell levels To strengthen the possibility that CCR5-disrupted HSPCs engraft patients will receive either a two- or three-day Cohort 1 or Cohort 2 course of busulfan dose targeting AUC of 4000 µMday before being infused with the genetically modified cells At 9-12 months after SB-728mR-HSPC infusion subjects who are aviremic with CD4 cell counts 600 cellsµL and have 1 CCR5-modified CD4 cells within the peripheral blood detected by pentamer PCR will undergo an ATI
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