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Gene Therapy Trial Browser
Clinical Trial Report
Gene Therapy Trial Report
Summary
Study of EBT-101 in Aviremic HIV-1 Infected Adults on Stable ART
NCTID
NCT05144386
(View at clinicaltrials.gov)
Description
This is a First in Human (FIH) study of EBT-101 administered IV to aviremic HIV-1 infected adults on stable antiretroviral therapy (ART).
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Development Status
Active
Indication
HIV-1-infection
Disease Ontology Term
DOID:526
Compound Name
EBT-101
Compound Description
AAV9-SaCas9-GagD-LTR1
Sponsor
Excision BioTherapeutics
Funder Type
Industry
Recruitment Status
Completed
Enrollment Count
6
Results Posted
Not Available
Therapy Information
Target Gene/Variant
HIV genes
Therapy Type
Gene editing
Therapy Route
In-vivo
Mechanism of Action
Gene excision
Route of Administration
Intravenous
Drug Product Type
Viral vector
Target Tissue/Cell
Lymphoid tissues
Delivery System
Viral transduction
Vector Type
AAV9
Editor Type
Cas9
Dose 1
0.9E12 vg/kg
Dose 2
3.0E12 vg/kg
Dose 3
Dose 4
Dose 5
Study Record Dates
Current Stage
Phase1
Submit Date
2021-11-22
Completion Date
2024-11-14
Last Update
2024-12-02
Participation Criteria
Eligible Age
18 Years - 70 Years
Standard Ages
Adult, Older adult
Sexes Eligible for Study
MALE
Locations
No.of Trial Sites
3
Locations
United States
Regulatory Information
Has US IND
True
FDA Designations
Fast Track, Regenerative Medicine Advanced Therapy
Recent Updates
Safe, but does not provide long-term viral suppression
Resources/Links
News and Press Releases
Excision BioTherapeutics Announces Data from the Phase 1/2 Trial of EBT-101 in HIV And In Vivo Efficacy Data in Herpes Virus and Hepatitis B
Preclinical Publications
Excision of HIV-1 DNA by gene editing: a proof-of-concept in vivo study
CRISPR based editing of SIV proviral DNA in ART treated non-human primates
Broad-Spectrum and Personalized Guide RNAs for CRISPR/Cas9 HIV-1 Therapeutics
Negative Feedback Regulation of HIV-1 by Gene Editing Strategy
Elimination of HIV-1 Genomes from Human T-lymphoid Cells by CRISPR/Cas9 Gene Editing
RNA-directed gene editing specifically eradicates latent and prevents new HIV-1 infection
Sequential LASER ART and CRISPR Treatments Eliminate HIV-1 in a Subset of Infected Humanized Mice
Preclinical safety and biodistribution of CRISPR targeting SIV in non-human primates
In Vivo Excision of HIV-1 Provirus by saCas9 and Multiplex Single-Guide RNAs in Animal Models
Removal of HIV DNA by CRISPR from Patient Blood Engrafts in Humanized Mice
Related NCTID
Long Term Follow-Up: NCT05143307