PD-1 Antibody SHR-1210 in Patients With Relapsed or Refractory Classic Hodgkin's Lymphoma

Inclusion Criteria

• Histologically confirmed classic Hodgkin's lymphoma;
• Relapsed or refractory cHL and meet any of the following criterions: a) did not achieve remission or progression after autologous hematopoietic stem cell transplantation. b) at least 2 lines of systemic chemotherapy and are not suitable for autologous stem cell transplantation;
• Subjects enrolled have measurable lesion (s) according to Lugano 2014 criteria;
• ECOG performance status of 0 or 1;
• Life expectancy ≥ 12 weeks;
• Adequate laboratory parameters during the screening period as evidenced by the following:
• Absolute neutrophil count ≥ 1.0 × 109/L;
• Platelets ≥ 75 × 109/L;
• Hemoglobin ≥ 8.0 g/dL;
• Total bilirubin (TBIL) 10mg; doses > 10 mg/day topical prednisone or equivalent are prohibited within 2 weeks before entering the group; (3) Received anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months before the first dose SHR-1210; (4) Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody; (5) Participating in other clinical studies or less than 4 weeks before the end of a clinical trial; (6) Known and highly Suspicion of interstitial pneumonia; (7) Other active malignancies that required treating. (subjects with skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma or cervical carcinoma who had no disease recurrence within 5 years after the start of treatment were excluded); (8) Received chemotherapy, radiotherapy, immunotherapy, including topical therapy within 4 weeks. Previous anti-tumor therapy related adverse reactions (except hair loss) did not recover to CTCAE ≤1; (9) Prior allo-HSCT; (10) ASCT within 90 days; (11) Impact of major surgery or severe trauma had been eliminated for less than 14 days; (12) Active pulmonary tuberculosis; (13) Severe acute or chronic infection requiring systemic therapy; (14) Suffering from heart failure (New York Heart Association standard III and given appropriate medical treatment. Uncontrolled coronary artery disease and arrhythmia. History of myocardial infarction within 6 months; (15) Inoculated with live vaccine within 4 weeks before receiving the investigational drug. Injections of inactivated influenza vaccine for seasonal influenza are permitted, but not live attenuated influenza vaccines for intranasal use.
• laboratory test:

(1) known HIV positive or known AIDS; (2) Untreated active hepatitis; co-infection with hepatitis B and hepatitis C.

• Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection.