STRIVE (Soluble T cell Receptors In Viral Eradication) is a Phase I/II first is human study sponsored by Immunocore Limited. It evaluates the safety, tolerability, pharmacokinetics/dynamics and anti-HIV activity of IMC-M113V (a monoclonal T cell receptor). The study looks at HLA-A*02:01-positive adults with HIV who are established on ART (antiretroviral therapy). The IMP is designed to target viral reservoirs that are unable to be killed by ART.

The current standard of care is lifelong ART which works to stop HIV from multiplying but doesn’t kill the HIV-infected cells so ,therefore, allows a normal lifespan but not a cure. It is hoped that the study drug will help to reduce the number of HIV-infected cells in the body and help control HIV without the need for lifelong ART.

The study is set up to be conducted in two stages. In the first stage eligible participants will receive a single ascending dose (SAD) of the study drug during ART. The aim of this part is to determine the safety, tolerability, and pharmacokinetics of ascending doses and to identify the lowest dose associated with pharmacodynamic (PD) effects.

In the second stage the participants will receive multiple ascending dose study (MAD) to determine the safety, tolerability and anti-HIV activity of serial infusions of the study drug and to identify the recommended dose for the next phase.

Objectives :

Stage 1:

• To evaluate the safety and tolerability of M113V when administered as a single dose during ART.

Stage 2:

• To evaluate the safety and tolerability of IMC-M113V when administered in a multiple dose schedule up to at least week 12 in subjects receiving ART.

Throughout both stages:

• To characterise the pharmacokinetic (PK) profile of IMC-M113V in single dose and multiple dose schedules
• To evaluate incidence of anti-IMC-M113V antibody formations following single and multiple infusions