Phase 1/2 study of IMC-M113V in virologically suppressed chronic HIV
An open-label dose-escalation study evaluating the safety, pharmacokinetics and antiviral activity of IMC-M113V in HLA-A*02:01 positive subjects with chronic HIV infection who are virologically suppressed
This is a first-in-human study that will look at a new type of treatment for HLA-A*02:01-positive adults with human immunodeficiency virus (HIV) infection called IMC-M113V (the investigational medicinal product (IMP)). The study aims to evaluate safety, tolerability, pharmacokinetics (what the body does to the study drug), pharmacodynamics (what the study drug does to the body) and anti-HIV activity of the IMP.
Antiretroviral therapy (ART), taken as daily tablets, is current standard of treatment for people living with HIV. However, ART is not able to kill HIV-infected cells; consequently, ART must be taken every day and if it is stopped, the virus comes back. In comparison, the IMP for this study modifies the body’s immune system to kill HIV-infected cells.
This study has 2 parts:
- Part 1 will look at different doses of the IMP to find the optimal and safest dose to use for Part 2 of the study. Up to 26 people will take part in this group. This part of the study will start with a very low IMP dose and will slowly increase the dose, only if smaller doses are shown to be safe. Once the single dose part of the study is completed and provided it is safe, part 2 will start. Part 1 comprises a maximum 28-day screening period, a 1-day treatment period involving a single administration of study drug, and a 28-day safety follow-up period.
- Part 2 will look at the IMP when given as multiple doses. Up to 28 people will take part in this group. Part 2 comprises a maximum 28-day screening period; a 12-week treatment period (weekly IMP administration in concurrence with a participant’s ART), an analytical therapy interruption of 12 weeks where IMP will not be administered, and a 12-week safety follow-up period.
East of England - Cambridge East Research Ethics Committee
Date of REC Opinion
26 Nov 2021
Further Information Favourable Opinion