Study of IMC-I109V in Non-cirrhotic HBeAg-negative Chronic HBV Infection

Exclusion Criteria

• •Parts 1 and 2:
• •Pregnant or lactating persons
• •Known co-infection with any of the following: HIV, Hepatitis C virus, OR Hepatitis D virus
• •Changes in HBeAg status within 3 months prior to the screening visit
• •Known HBV genotype A
• •Gilbert's syndrome
• •Any known pre-existing medical or psychiatric condition that could interfere with the participant's ability to provide informed consent or participate in study conduct, or that may confound study findings including, but not limited to: Immunologically-mediated disease, e.g. inflammatory bowel disease (Crohn's disease, ulcerative colitis), rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, scleroderma, or sarcoidosis within 5 years of the screening visit.
• •Current or history of any clinically significant cardiac abnormalities/dysfunction, e.g. congestive heart failure, myocardial infarction ≤6 months prior to the screening visit, pulmonary hypertension, complex congenital heart disease, significant arrhythmia, or active cardiac ischemia.
• •Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding esophageal varices, hepatorenal syndrome, or hepatic encephalopathy.
• •Significant immunosuppression from, but not limited to immunodeficiency conditions such as common variable hypogammaglobulinemia
• •Receiving or planning to receive systemic immunosuppressive medications during the study or ≤ 2 months prior to Day1, including but not limited to prednisone \>10 mg/day (or equivalent), methotrexate, cyclosporine, or interferon. NOTE: Local steroid therapy is allowed (eg, inhaled, otic, ophthalmic, or intra-articular medications)
• •Use of any live vaccines against infectious diseases within 4 weeks of the first planned administration of study intervention or use of any non-live vaccines against infectious diseases within 2 weeks of the first planned administration of study intervention.
• •Treatment with any investigational drug or enrollment in any other clinical study ≤ 3 months prior to Day1, or at any time during participation in the study.
• •Clinical diagnosis of substance abuse with alcohol, narcotics, or cocaine ≤12 months prior to the screening visit, except for those participants monitored in an opioid substitution maintenance program.
• •Part 3:
• •Pregnant or lactating persons
• •Untreated or symptomatic CNS metastases
• •Significant ongoing toxicity from prior anticancer treatment -
• •Ascites requiring recurrent paracentesis
• •Inadequate washout from prior anticancer therapy
• •Prior cellular therapy for HBV-associated HCC
• •Known HBV genotype A
• •Decompensated liver disease
• •Surgical intervention or local / loco-regional therapy for HBV HCC within 28 days of planned first dose of study treatment
• •Active hepatitis C virus (HCV) infection
• •Untreated HIV infection
• •Significant secondary malignancy
• •Clinically significant lung, heart, or autoimmune disease
• •Ongoing requirement for immunosuppressive treatment
• •Prior solid organ or bone marrow transplant
• •Hypersensitivity to study drug or excipients, or pre-medications
• •Systemic antibiotics, vaccines or major surgery within 2-4 weeks prior to the first dose of study intervention
• •Out-of-range laboratory values, including ALT or AST \> 3x upper limit of normal (ULN), total bilirubin and direct bilirubin \> 1.5x ULN, Albumin ≤ 28 g/L, International normalized ratio (INR) \> 1.3