Efficacy and Safety Evaluation of IBI308 in Treatment of Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma

Inclusion Criteria

• Histopathological confirmed classical Hodgkin's lymphoma (cHL).
• Relapsed/refractory cHL, which failed second line and above therapy (including radiotherapy and autologous hematopoietic stem cell transplantation, ASCT); subject with no response to or with progression after ASCT is eligible.
• At least one measurable disease (long axis>15 mm or short axis>10 mm, with uptake on 18FDG-PET)
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2.
• Signed written informed consent form and willing and able to comply with scheduled visits and other requirements of the study.
• Age ≥ 18.
• Life expectancy of at least 12 weeks.
• Subjects of reproductive potential must be willing to use adequate contraception during the course of the study and through 90 days after the last dose of study medication.
• Adequate organ and bone marrow function:
• Count of Blood Cells: absolute neutrophil count (ANC) ≥ 0.75 × 109 / L; platelet count (PLT) ≥ 50 × 109 / L; hemoglobin content (HGB) ≥ 8.0 g / dL; no granulocyte colony-stimulating factor, platelet or red blood cells infusion in the last 14 days.
• Liver function: total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.
• Renal function: serum creatinine (Cr) ≤ 1.5 × ULN.
• Thyroid function: thyroid stimulating hormone (TSH) in normal range (TSH abnormalities due to non-autoimmune causes can be enrolled).

Exclusion Criteria

• Known nodular lymphocyte predominant Hodgkin lymphoma.
• Known central nervous system lymphoma.
• Received ASCT within 90 days of the first dose of study medication.
• Prior exposure to any anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody.
• Currently participating in an interventional clinical study, unless participating in observational study or during follow-up period of an interventional study.
• Received any investigational agent within 4 weeks of the first dose of study medication.
• Received last dose of radiotherapy or anti-tumor therapy (chemotherapy, targeted therapy, tumor immunotherapy or arterial embolization) within 3 weeks of the first dose of study medication; received last dose of nitrosourea or mitomycin C within 6 weeks of the first dose of study medication.
• Received systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 4 weeks of first dose. Inhaled or topical steroids and adrenal replacement steroid doses are permitted in the absence of active autoimmune disease.
• Received a live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period.
• Underwent major operation (craniotomy, thoracotomy or laparotomy) within 4 weeks of the first dose of study medication or open wound, ulcer or fracture.
• Activated, known or suspected autoimmune diseases or history of the disease with two years before enrollment. Vitiligo, psoriasis, hair loss, or Graves disease which do not need systemic treatment in 2 years, or hypothyroidism which only need thyroid hormone replacement therapy, or type-1 diabetes which only need insulin replacement therapy is eligible for enrollment.
• Known primary immunodeficiency disorders.
• Active tuberculosis.
• Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation.
• Known allergy or hypersensitivity to any monoclonal antibodies or any components used in their preparation.
• Uncontrolled concomitant disease, including but not limited to :
• Human Immunodeficiency Virus (HIV) infection (HIV antibody positive)
• Active or poorly controlled severe infection
• Symptomatic congestive heart failure (New York Heart Association grade Ⅲ-IV) or symptomatic, poorly controlled arrhythmia
• Poorly controlled arterial hypertension (SBP ≥ 160mmHg or DBP ≥ 100mmHg) with standard treatment
• Prior arterial thromboembolism event, including my