2024-11-28
minor
Study Status, Study Description, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v2
Enrollment target12→28
Study sites15→17
Study arms2→4
InterventionsANB-002, dose 1 (Genetic), ANB-002, dose 2 (Genetic)→ANB-002, dose 1 (Genetic), ANB-002, dose 2 (Genetic), ANB-002, dose 3 (Genetic)
Eligibility criteria+36 characters
[...] od or hematopoietic disorders.
Positive Anti-AAV5 antibodies (for Cohorts 1-3).
Diagnosed HIV-infection, not controlled with anti-viral therapy.
Hepatitis B (for Cohorts 1-3), acute or chronic hepatitis C.
Any active systemic infectio [...]
Study description+283 characters
The study design includes ANB-002 dose escalation in at least twothree cohorts.
In Cohort 1, the subject is treated with a single dose of ANB-002 (dose 1) administered as an intravenous infusion.
Follow-up for the a [...] ort 1, the following subjects will be included in Cohort 1.
In Cohort 2, the subjects are treated with a single dose of ANB-002 (dose 2).
In Cohort 3, the subject are treated with a single dose of ANB-002 (dose 3).
The decision to continue enrolling in Cohort 1 or dosing in Cohort 2 subjectscohorts will be made at the Independent Data Monitoring Committee ( [...] eting.
After the IDMC make [...]