A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies

Inclusion Criteria

• Signed Informed Consent.
• Age ≥ 18 years.
• Part 1: Patients with histologically confirmed relapsed or refractory B-cell malignancies, including Grades 1-3a FL, MZL, MCL, and CLL/SLL. Part 2: Patients with histologically confirmed B-cell malignancies including r/r FL, r/r MZL and CLL/SLL with/without prior treatment.
• Life expectancy (in the opinion of the investigator) of ≥ 4 months.
• ECOG performance status of 0 ~1.
• Must have adequate organ function.
• Negative test results for HBV ([HBsAg (-)] and non-active HBV or HCV infection

Exclusion Criteria

• Pregnant or breast-feeding or intending to become pregnant during the study.
• Prior treatment with systemic immunotherapeutic agents.
• Known allergies to Orelabrutinib (ICP-022) or its excipients or infection with HIV.
• Treatment with any chemotherapeutic agent, or any other investigational therapies within 4 weeks prior to first dose of the study drug.
• History of allogeneic stem-cell (or other organ) transplantation or confirmed progressive PML.
• Any external beam radiation therapy within 6 weeks prior to the first dose of the study drug.
• Concurrent use of warfarin or other vitamin K antagonists or anticoagulation therapies or strong CYP3A inhibitor.
• Active uncontrolled infections.
• Recent infection requiring IV anti-infective treatment that was completed ≤ 14 days before the first dose of study drug.
• Unresolved toxicities from prior anti-cancer therapy.
• Medically apparent CNS lymphoma or leptomeningeal disease.
• Current or previous history of CNS disease.
• Major surgery or significant traumatic injury < 28 days prior to the first dose of the study drug.
• Patients with another invasive malignancy in the last 2 years.
• Significant cardiovascular disease or active pulmonary disease.
• Received systemic immunosuppressive medications.