The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies

Exclusion criteria

• . History of another malignancy, except for the following:
• . Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to the start of AVM0703 administration, angina requiring therapy, symptomatic peripheral vascular disease, New York Heart Association Class III or IV congestive heart failure, left ventricular ejection fraction \<30%, left ventricular fractional shortening \<20%, or uncontrolled ≥Grade 3 hypertension (diastolic blood pressure \>100 mmHg or systolic blood pressure \>150 mmHg) despite antihypertensive therapy for patients ≥18 years of age, or uncontrolled stage 2 hypertension (diastolic blood pressure \>90 mmHg or systolic blood pressure \>140 mmHg) despite antihypertensive therapy for patients ≥12 years of age;
• . Significant screening electrocardiogram (ECG) abnormalities, including unstable cardiac arrhythmia requiring medication, atrial fibrillation/flutter, second degree atrioventricular (AV) block type 2, third-degree AV block, ≥Grade 2 bradycardia, or heart rate corrected QT interval using Fridericia's formula \>480 msec;
• . Known gastric or duodenal ulcer;
• . Uncontrolled type 1 or type 2 diabetes;
• . Known hypersensitivity or allergy to the study drug or any of its excipients;
• . Untreated ongoing bacterial, fungal, or viral infection (including upper respiratory tract infections) at the start of AVM0703 administration, including the following:
• . Received live vaccination within 8 weeks of screening;