An open-label dose-escalation study evaluating the safety, pharmacokinetics and antiviral activity of IMC-M113V in HLA-A*2:01 positive subjects with chronic HIV infection who are virologically suppressed.

Chronic HIV infection

• Incidence and severity of treatment-emergent adverse events (TEAEs) • Incidence of dose-limiting toxicities (DLTs) • Changes in safety laboratory parameters, vital signs, and electrocardiogram (QTcF) • Incidence of serious adverse events (SAEs) and AEs leading to treatment interruption, dose reduction, or discontinuation through 28 days after the last infusion of study treatment

IMC-M113V pharmacokinetics (PK) parameters (eg, AUC, Cmax, Tmax, t1/2) at multiple time points from baseline up to 72 hours post-dose in SAD and MAD (first dose) and after each subsequent dose in MAD studies Incidence of anti-IMC-M113V antibody formation following administration of one or more doses of study drug, Change in serum cytokines/chemokines and peripheral blood lymphocyte counts (absolute values and fold-change) from baseline through 72 hours post-dosing with IMC-M113V in SAD and MAD schedules and during Follow-Up., • Proportion of participants with pVL < 200 copies/mL 12 weeks after interruption of ART (W24) • Proportion of participants resuming ART before W24 • Duration of post-treatment control (pVL < 200 copies/mL) after interruption of ART • Duration of virological suppression (pVL <1000 copies/mL) after interruption of ART Identification of at least 1 tolerable dosing regimen for further evaluation in subsequent development

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Belgium, Spain