A Clinical Study of SHR-3079 in B-cell Non-Hodgkin Lymphoma

Inclusion criteria

• Aged ≥ 18 years old;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, expected survival ≥ 3 months;
• Histologically confirmed B-NHL;
• Participant population: Have received ≥ 1 line of standard anti-tumor treatment, and have not achieved response after the latest treatment or have progressive disease after the treatment;
• Have measurable lesions;
• Have adequate organ function;
• Male participants and female participants of childbearing potential must use adequate and effective contraceptive measures during the study and within 3 months after the last drug administration of SHR-3079. Female participants must not be lactating and must have a negative blood HCG test result within 7 days before the first dose;
• Voluntarily sign the ICF, have good compliance, and be willing to cooperate with follow-up.

Exclusion criteria

• Central nervous system (CNS) infiltration;
• Prior chemotherapy or other anti-lymphoma agents administered within 4 weeks before the first dose of study treatment;
• Major surgery within 4 weeks before signing the ICF, or plan to undergo major surgery during the study period;
• Receipt of CAR-T therapy or autologous stem cell transplant within 12 weeks prior to enrollment;
• Receipt of allogeneic hematopoietic stem cell transplantation;
• Prior solid organ transplantation;
• Positive hepatitis C virus (HCV) antibody with HCV-RNA copy number above the upper limit of normal of the study site; positive hepatitis B surface antigen [HBsAg] and/or positive hepatitis B core antibody (HBcAb) with HBV DNA copy number above the upper limit of normal of the study site;
• Presence of severe disorders involving major organ systems;
• Pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention;
• Pregnant, lactating women, or women planning to become pregnant;
• Have other serious physical or mental illness, laboratory test abnormalities, or other factors that may increase the risk of study participation or interfere with the study results.