NCT05143307

Brief Summary

Participants who receive EBT-101 in a parent protocol will be eligible to participate in this long-term follow-up (LTFU) study (EBT-101-002).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
132mo left

Started Jul 2023

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Jul 2023Apr 2037

First Submitted

Initial submission to the registry

November 22, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
1.6 years until next milestone

Study Start

First participant enrolled

July 11, 2023

Completed
13.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2037

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2037

Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

13.5 years

First QC Date

November 22, 2021

Last Update Submit

May 13, 2024

Conditions

HIV-1-infection

Keywords

CRISPRGene Therapyadeno-associated virus serotype 9 (AAV9)

Outcome Measures

Primary Outcomes (1)

  • Long-term safety of EBT-101

    Long-term safety of EBT-101 will be assessed based on incidence and severity of clinically significant adverse events (AEs) according to Division of AIDS (DAIDS) 2017 over 15 years

    15 years

Study Arms (1)

Long Term Follow Up

EXPERIMENTAL

Participants who received EBT-101 in a parent study will undergo long term follow up

Biological: EBT-101

Interventions

EBT-101BIOLOGICAL

Long term follow up of participants who received EBT-101

Long Term Follow Up

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing and able to provide written, signed informed consent
  • Participants who received the investigational study intervention EBT-101 in a parent study

You may not qualify if:

  • Participants who did not receive EBT-101 in a parent study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Quest Clinical Research

San Francisco, California, 94115, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Cooper Health

Camden, New Jersey, 08103, United States

Location

Study Officials

  • William Kennedy, MD

    Excision BioTherapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Long term follow up of participants who received EBT-101
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2021

First Posted

December 3, 2021

Study Start

July 11, 2023

Primary Completion (Estimated)

January 1, 2037

Study Completion (Estimated)

April 1, 2037

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(3)