Clinical Trial

Disease: Human Immunodeficiency Virus Infection, HIV (NCT02388594)

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 I Study of T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728mR in HIV-Infected Patients, With or Without the CCR5 Delta-32 Mutation, Pre-treated With Cyclophosphamide.
Who:

No information 

Sponsor:

University of Pennsylvania

Partners:

National Institute of Allergy and Infectious Diseases (NIAID)

Locations:

United States, Pennsylvania

Study start:
Apr. 1, 2015
Enrollment:
14 participants
Gene editing method:
ZFN- Zinc Finger Nucleases
Type of edit:
Gene knock-out
Gene:
C-C motif chemokine receptor 5 (CCR5)
Delivery method:
mRNA electroporated - Ex-vivo
Trial link:
https://clinicaltrials.gov/ct2/show/study/NCT02388594
Safety updates:

No information

Other links:

LinkHIV Infection InformationLinkHIV around the worldLinkZFN Technology Platform

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

Status: Completed

Description

This is a triple cohort, open-label pilot study of the safety and antiviral activity of a single infusion of autologous CD4+ T cells genetically modified at the CCR5 gene by Zinc Finger Nucleases SB-728mR (ZFN Modified CD4+ T Cells) using electroporated mRNA with or without the prior administration of two different doses of cyclophosphamide.

Experimental: ZFN Modified CD4+ T Cell
ZFN Modified CD4+ T Cell

Last updated: Jun. 5, 2023
Source: US National Institutes of Health (NIH)
clinicaltrials.gov
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