A Study of OL-108 in Relapsed/Refractory Autoimmune Diseases

Exclusion Criteria

• •Active uncontrolled infection
• •Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load
• •Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load
• •HIV antibody positive
• •Syphilis antibody positive
• •Active tuberculosis, untreated or inadequately treated latent tuberculosis infection (LTBI)
• •History of serious infection within 3 months prior to screening (defined as requiring hospitalization or intravenous antimicrobial therapy), or history of oral antimicrobial therapy within 1 month prior to screening (e.g., viral infections, opportunistic infections, including but not limited to severe cytomegalovirus or herpes virus infections)
• •Congenital long QT syndrome or a corrected QTcF interval of ≥480 ms at screening (unless secondary to pacemaker or bundle branch block)
• •Uncontrolled hypertension (blood pressure ≥160/100 mm Hg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes or other endocrine diseases, severe chronic pulmonary disease, or other serious medical condition which is likely to significantly impair the patient's ability to tolerate the study treatment
• •history of organ transplant
• •Pregnancy or lactating women
• •Use of any other experimental medication within 4 weeks or 5 half-lives prior to start of study drug
• •Use of biologics within 3 months, stem cell transplant or CAR-T within 6 months prior to the start of study drug
• •Received live or attenuated vaccine within 4 weeks of Cycle 1 Day 1
• •Presence of other autoimmune or auto-inflammatory diseases that may affect study assessments, such as rheumatoid arthritis, gout, or active fibromyalgia syndrome.
• •Limited to patients diagnosed with SLE: patients with active neuropsychatric SLE
• •Limited to patients diagnosed with IIM: Severe involvement of respiratory muscles affecting ventilatory function; permanent muscle weakness related to IIM; other inflammatory or non-inflammatory myopathy: inclusion body myositis, infectious myopathy, metabolic myopathy, muscular dystrophy or a family history of muscular dystrophy, drug-induced or endocrine-induced myositis, and juvenile myositis
• •Limited to patients diagnosed with SSc: at risk for scleroderma renal crisis; SSc-associated gastric antral vascular ectasia; Severe gastrointestinal involvement leading to malabsorption or intestinal failure
• •Limited to patients diagnosed with AAV: Central nervous system vasculitis; Alveolar hemorrhage requiring invasive pulmonary ventilation