Safety and Preliminary Efficacy Study of MRG001 in Patients With Non-Hodgkin Lymphoma (NHL)

Exclusion Criteria

• •1. Applicable to Phase Ia: positive hepatitis B surface antigen (HBsAg), or negative HBsAg with a peripheral blood hepatitis B virus DNA copy number greater than the upper limit of normal; positive hepatitis C virus (HCV) antibody and positive HCV RNA at screening. Patients with a history of clinically significant non-viral hepatitis and cirrhosis. Applicable to Phase Ib: positive hepatitis B surface antigen (HBsAg) and/or positive hepatitis B core antibody (HBcAb) at screening, and peripheral blood hepatitis B virus DNA copy number greater than the upper limit of normal; positive hepatitis C virus (HCV) antibody and positive HCV RNA. Patients with a history of clinically significant non-viral hepatitis and cirrhosis (decompensated cirrhosis Child-Pugh class B, C).
• •2. Positive human immunodeficiency virus (HIV) antibody.
• •3. Any active infection requiring systemic therapy occurred within 2 weeks before enrollment.
• •4. Suspected or confirmed central nervous system invasion of NHL.
• •5. Allergic constitution or known hypersensitivity to rituximab or other anti-CD20 monoclonal antibodies and their components, or hypersensitivity to any component of MRG001.
• •6. Patients with uncontrolled or significant cardiovascular disease.
• •7. History of severe pulmonary disease.
• •8. Received CAR-T therapy within 3 months before enrollment.
• •9. Received blood transfusion within 28days before enrollment, or receiced erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF) and other drugs that may affect hemogram within 14 days before enrollment.
• •10. Current use of potent CYP3A4 inhibitors or inducers.
• •11. History of allogeneic stem cell transplantation or organ transplantation, or have received autologous stem cell transplantation within 3 months prior to screening, or plan to undergo stem cell transplantation.
• •12. Suffered from other malignancies within the last 5 years.
• •13. Major surgery within 6 weeks prior to enrollment or planned major surgery within the first 12 weeks after receiving study drug.
• •14. Patients who are receiving any approved or investigational anti-tumor treatment with antibody/fusion protein/ADC drugs, radiotherapy, chemotherapy, Chinese patent medicine or Chinese herbal medicine within 28 days before enrollment; or have participated in any approved or investigational small molecule targeted therapy within 28 days before enrollment or within 5 half-lives (whichever is shorter).
• •15. Received any vaccine within 28 days prior to enrollment or will receive any vaccine within 6 months after the last dose of study drug.
• •16. Requires treatment with glucocorticoids or other immunosuppressive agents for a certain condition within 14 days prior to enrollment.
• •17. An acute oncolytic reaction may occur at the discretion of the investigator.
• •18. Inability to complete protocol-specified study visits and study drug administration.
• •19. Women during pregnancy or lactation; men and women of childbearing potential who are unwilling to take prescribed appropriate contraceptive measures.
• •20. Other conditions inappropriate for participation in this clinical trial at the discretion of the investigator.
• •21. Malignant lymphoma with pathological transformation.
• •22. High-grade B-cell lymphoma.
• •23. Patient's Body Mass Index ≤ 17 kg/m2.
• •24. Patients with underlying medical conditions that, in the judgment of the investigator, might increase the risk of receiving study drug or might affect the safety assessment of the study drug.