Clinical Trial

Disease: Human Immunodeficiency Virus Infection, HIV, (NCT02225665)

Disease info:

HIV stands for human immunodeficiency virus. It harms the immune system by destroying the white blood cells that fight infection. This puts at risk for serious infections and certain cancers.

AIDS stands for acquired immunodeficiency syndrome. It is the final stage of infection with HIV. Not everyone with HIV develops AIDS.

Frequency:
Worldwide, there were about 1.7 million new cases of HIV in 2018. About 37.9 million people were living with HIV around the world in 2018, and 23.3 million of them were receiving medicines to treat HIV, called antiretroviral therapy (ART).
Official title:
A Phase 1/2, 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
Who:

Study Director:Winson Tang, MD Sangamo BioSciences, Inc.

Sponsor:

Sangamo BioSciences, Inc.

Partners:
Locations:

United States, California

United States, Connecticut

United States, Florida

United States, Texas

 

Study start:
Aug. 1, 2014
Enrollment:
12 participants
Gene editing method:
ZNF-Zinc Finger Nucleases
Type of edit:
Gene knock-out
Gene:
C-C motif chemokine receptor 5 (CCR5)
Delivery method:
mRNA transfection - Ex-vivo
Trial link:
https://clinicaltrials.gov/ct2/show/study/NCT02225665
Safety updates:

(11-12-2015) Sangamo BioSciences Presents Phase 2 Clinical Data From Two SB-728-T HIV Studies

Other links:

LinkHIV infection informationLinkHIV around the wolrdLinkZFN Technology PlatformLinkDiversifying the structure of zinc finger nucleases for high-precision genome editing

IndicatorIndicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Completed

Description

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.

Last updated: Apr. 10, 2022
Source: US National Institutes of Health (NIH)
clinicaltrials.gov
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