Clinical Trial

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

Disease info:

Human immunodeficiency virus (HIV) is a virus that attacks the immune system by infecting and killing white blood cells known as CD4+ T-cells. CD4+ T-cells represent a vital part of the immune system and untreated HIV infections render patients more vulnerable to dangerous infections by other pathogens, including bacteria and fungi. If the virus remains untreated it can lead to patients developing the life-threatening disease acquired immunodeficiency syndrome (AIDS). Untreated HIV can leave people vulnerable to life-threatening infections. HIV symptoms often manifest as flu-like symptoms such as fever, chills, rash, night sweats, muscle aches, sore throat, and fatigue. Today, antiviral medications can allow people living with HIV to live healthy lives.

Frequency:
In 2021, 36,136 people received an HIV diagnosis in the United States and dependent areas. An estimated 1.2 million people in the United States had HIV at the end of 2021.
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

San Francisco, California, United States, 94115

 

United States, Connecticut

Norwalk, Connecticut, United States, 06850

 

United States, Florida

Orlando, Florida, United States, 32803

 

United States, Texas

Austin, Texas, United States, 78705

Dallas, Texas, United States, 75246

 

Study start:
Aug. 1, 2014
Enrollment:
8 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: Dec. 28, 2023
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