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

Summary

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.

Eligibility

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.

Conditions2

Interventions1

Browse More Trials