History of Changes for Study: NCT05144386

Study of EBT-101 in Aviremic HIV-1 Infected Adults on Stable ART

Latest version (submitted May 14, 2024) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	November 22, 2021	None (earliest Version on record)
2	January 13, 2022	Study Status
3	January 24, 2022	Recruitment Status, Contacts/Locations and Study Status
4	January 27, 2022	Contacts/Locations and Study Status
5	February 16, 2022	Study Status, Eligibility and Study Description
6	March 4, 2022	Contacts/Locations and Study Status
7	March 24, 2022	Eligibility and Study Status
8	October 17, 2022	Contacts/Locations, Eligibility and Study Status
9	February 27, 2023	Contacts/Locations, Eligibility, Study Status and Study Description
10	March 7, 2023	Contacts/Locations and Study Status
11	August 4, 2023	Eligibility, Study Status and Contacts/Locations
12	November 3, 2023	Contacts/Locations and Study Status
13	May 14, 2024	Recruitment Status, Contacts/Locations, Study Status, Arms and Interventions, Study Design, Eligibility, Conditions and Oversight

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Study NCT05144386
Submitted Date: November 22, 2021 (v1)

Study Identification


Unique Protocol ID:	EBT-101-001
Brief Title:	Study of EBT-101 in Aviremic HIV-1 Infected Adults on Stable ART
Official Title:	A Phase 1/2a, Sequential Cohort, Single Ascending Dose Study of the Safety, Tolerability, Biodistribution, and Pharmacodynamics of EBT 101 in Aviremic HIV-1 Infected Adults on Stable Antiretroviral Therapy
Secondary IDs:

Study Status


Record Verification:	November 2021
Overall Status:	Not yet recruiting
Study Start:	December 2021
Primary Completion:	December 2024 [Anticipated]
Study Completion:	March 2025 [Anticipated]

First Submitted:	November 22, 2021
First Submitted that Met QC Criteria:	November 22, 2021
First Posted:	December 3, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	November 22, 2021
Last Update Posted:	December 3, 2021 [Actual]

Study Description

Brief Summary:

This is a First in Human (FIH) study of EBT-101 administered IV to aviremic HIV-1 infected adults on stable antiretroviral therapy (ART).

Detailed Description:

This is a FIH, open-label, sequential cohort, single ascending dose (SAD) study of EBT-101 administered IV to aviremic HIV-1 infected adults on stable ART.

On Day 1, eligible participants will receive a single IV dose of EBT-101. All participants will be assessed for eligibility for an analytical treatment interruption (ATI) of their background ART at Week 12. All participants will be followed through Week 48; participants who undergo ATI will have more frequent study visits than non-ATI participants.

Eligible participants who are enrolled in the FIH study (EBT-101-001) will also be enrolled in a separate Long Term Follow Up (LTFU) study (EBT-101-002) for safety monitoring. The duration of the LTFU study will be up to 15 years.

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1
Interventional Study Model:	Sequential Assignment
Number of Arms:	3
Masking:	None (Open Label)
Allocation:	Non-Randomized
Enrollment:	9 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: EBT-101 Dose-Level 1 Cohort A: Participants will be administered dose-level 1 of EBT-101	Biological: EBT-101 EBT-101 is a HIV-1-specific clustered regularly interspaced short palindromic repeats (CRISPR)/Cas9 gene editing system delivered by adenovirus-associated virus vector serotype 9 (AAV9) for intravenous (IV) administration
Experimental: EBT-101 Dose-Level 2 Cohort B: Participants will be administered dose-level 2 of EBT-101	Biological: EBT-101 EBT-101 is a HIV-1-specific clustered regularly interspaced short palindromic repeats (CRISPR)/Cas9 gene editing system delivered by adenovirus-associated virus vector serotype 9 (AAV9) for intravenous (IV) administration
Experimental: EBT-101 Dose-Level 3 Cohort C: Participants will be administered dose-level 3 of EBT-101	Biological: EBT-101 EBT-101 is a HIV-1-specific clustered regularly interspaced short palindromic repeats (CRISPR)/Cas9 gene editing system delivered by adenovirus-associated virus vector serotype 9 (AAV9) for intravenous (IV) administration

Outcome Measures


Primary Outcome Measures:
1.	Safety and Tolerability of EBT-101 [ Time Frame: 48 weeks ] Safety and tolerability of EBT-101 will be assessed based on the incidence and severity of adverse events (AEs) according to Division of AIDS (DAIDS) 2017 over 48 weeks

Eligibility


Minimum Age:	18 Years
Maximum Age:	60 Years
Sex:	Male
Gender Based:	Yes
	Cohort A will enroll male adults (sex at birth)
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria (abbreviated): Participants 18 to 60 years of age inclusive, at the time of signing the informed consent. Documented chronic HIV-1 infection on stable ART regimen Plasma HIV-1 levels below the limit of quantification Peripheral blood cluster of differentiation 4 (CD4) T cell count >500 cells/mm3 during screening Have previously been vaccinated for N. meningitidis with documented history and/or received a N. meningitidis vaccination prior to dosing Must be willing to use condoms throughout the duration of the study Willing to enroll into the Long-Term Follow-Up Study, EBT-101-002, for up to 15 years after receiving study drug Exclusion Criteria (abbreviated): Anti-AAV9 serum neutralizing antibodies >1:20 titer History of one or more HIV-related opportunistic infections within the past 2 years Documented prior HIV-1 drug resistance to ≥2 or more classes of ART defined as a single key mutations or an accumulation of minor mutations that result in resistance to entire respective drug classes within the past 5 years History of >1 change in ART due to virologic failure during preceding 2 years. Receiving or plans to receive long-acting injectable ART History of malignancy with the exception of successfully treated basal cell or squamous cell carcinoma of the skin

Contacts/Locations


Central Contact Person:	Study Director at ExcisionBio Telephone: 833-214-2241 Email: clinicalscience@excisionbio.com
Central Contact Backup:	Study Lead at ExcisionBio Email: clinicalscience@excisionbio.com
Study Officials:	Study Director Study Director Excision BioTherapeutics
Locations:	United States, California
	Clinical Trial Site San Francisco, California, United States, 94110 Contact:Contact: Study Coordinator
	United States, Florida
	Clinical Trial Site Orlando, Florida, United States, 32803 Contact:Contact: Study Coordinator
	United States, Missouri
	Clinical Trial Site Saint Louis, Missouri, United States, 63110 Contact:Contact: Study Coordinator
	United States, New Jersey
	Clinical Trial Site Camden, New Jersey, United States, 08103 Contact:Contact: Study Coordinator

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