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

An Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-3079 Injection in Participants With B-Cell Non-Hodgkin Lymphoma

The study is being conducted to evaluate the safety and tolerability of SHR-3079, and to explore the Dose-limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of SHR-3079 in patients with B-cell non-Hodgkin lymphoma.

Inclusion Criteria:

1. Aged ≥ 18 years old;
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, expected survival ≥ 3 months;
3. Histologically confirmed B-NHL;
4. 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;
5. Have measurable lesions;
6. Have adequate organ function;
7. 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;
8. Voluntarily sign the ICF, have good compliance, and be willing to cooperate with follow-up.

Exclusion Criteria:

1. Central nervous system (CNS) infiltration;
2. Prior chemotherapy or other anti-lymphoma agents administered within 4 weeks before the first dose of study treatment;
3. Major surgery within 4 weeks before signing the ICF, or plan to undergo major surgery during the study period;
4. Receipt of CAR-T therapy or autologous stem cell transplant within 12 weeks prior to enrollment;
5. Receipt of allogeneic hematopoietic stem cell transplantation;
6. Prior solid organ transplantation;
7. 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;
8. Presence of severe disorders involving major organ systems;
9. Pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention;
10. Pregnant, lactating women, or women planning to become pregnant;
11. 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.