Pomalidomide Plus Orelabrutinib and Zuberitamab in Untreated Mantle Cell Lymphoma

Exclusion Criteria

• •Current central nervous system involvement or suspected patients and those with a history of this condition
• •Previously received systemic treatment for MCL, including BTKi.
• •Uncontrolled active systemic fungal, bacterial, or viral infections (defined as persistent signs/symptoms related to the infection despite the use of appropriate antibiotics, antiviral therapy, and/or other treatments with no improvement).
• •Known human immunodeficiency virus (HIV) infection, or the following serological status indicating active hepatitis B or C virus infection:
• •1. Subjects with positive hepatitis B virus core antibody (HBcAb) and negative surface antigen (HBsAg) must have a negative polymerase chain reaction (PCR) result prior to the first dose. Subjects with positive HBsAg or HBV-DNA:
• •2. Subjects with positive hepatitis C antibodies must have an HCV-RNA negative result before the first dose. Subjects with positive hepatitis C PCR results will not be eligible for this study.
• •Clinically severe cardiovascular diseases, including:
• •1. Myocardial infarction occurring within the 6 months prior to screening;
• •2. Unstable angina occurring within 3 months prior to screening;
• •3. Clinically significant arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes ventricular tachycardia);
• •4. QTcF (corrected by Fridericia's formula) \> 480 msec;
• •5. History of second-degree type II atrioventricular (AV) conduction block or third-degree atrioventricular conduction block;
• •6. III or IV congestive heart failure as defined by the New York Heart Association (NYHA)
• •History of severe hemorrhagic disorders, such as hemophilia A, hemophilia B, von Willebrand disease, or a history of spontaneous bleeding requiring blood transfusion or other medical interventions.
• •History of deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past 12 months
• •History of significant cerebrovascular disease/events within 6 months prior to the first administration of the investigational drug, including stroke or intracranial hemorrhage.
• •Unable to swallow capsules or having significant gastrointestinal functional disorders, such as malabsorption syndrome, gastric or small intestine resection, symptomatic inflammatory bowel disease, or partial or complete intestinal obstruction.
• •Continuous treatment with strong and moderate CYP3A inhibitors or CYP3A inducers is required. If the patient has taken strong or moderate CYP3A inhibitors or inducers within 7 days prior to the first dose of the investigational drug (or has taken these drugs for less than 5 half-lives), they cannot be enrolled. Patients using moderate CYP3A inhibitors can be considered for the study after at least a 7-day washout period.
• •Anticoagulation treatment with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) is required within 7 days after the first dose of the investigational drug or receiving anticoagulation therapy.
• •Pregnant or breastfeeding women
• •Hypersensitivity to any investigational drug
• •Any mental or cognitive impairment that may limit their understanding, execution, and compliance with the informed consent form and the study.
• •Subjects with drug abuse and alcoholism