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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).
(Show More)
Indication
HIV-1 Infection, subgroup B
Compound Name
EBT-101 (AAV9-SaCas9-GagD-LTR1)
Sponsor
Excision BioTherapeutics
Funder Type
Industry
Status
Active not recruiting
Enrollment Count
6
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
Delivery System
Viral transduction
Vector Type
AAV9
Editor Type
Cas9
Dose 1
0.9 x 10^12 vg/kg
Dose 2
3.0 x 10^12 vg/kg
Dose 3
Dose 4
Dose 5
Study Record Dates
Current Stage
Phase1
Submit Date
2021-11-22
Completion Date
2025-05
Last Update
2024-07-29
Participation Criteria
Eligible Age
18 Years - 70 Years
Standard Ages
Adult, Older adult
Eligible Sex
MALE
Locations
No.of Trial Sites
3
Locations
United States
Regulatory Information
Has US IND
True
Recent Updates
Safe, but does not provide long-term viral suppression
Resources/Links
Patents
US20190367924A1
US20200392487A1
US20240139294A1
Grant
R01 MH115860
R01 MH110360
R01 HL114152
R56 AI143647
R56 AI150772
R01 DA042706
CLIN2-13310
R01 NS087971
News and Press Releases
https://www.excision.bio/news/press-releases/detail/43/excision-biotherapeutics-announces-data-from-the-phase-12
Preclinical Publications
PMID: 31266936
PMID: 30195766
PMID: 33247091
PMID: 27194423
PMID: 37587230
PMID: 28366764