PD-1 Antibody SHR-1210 in Patients With Relapsed or Refractory Classic Hodgkin's Lymphoma
Condition: Hodgkin Lymphoma, Adult
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: SHR-1210
Intervention description: A humanized monoclonal immunoglobulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open-label, multicenter, non-randomized, phase 2 trial to evaluate efficacy and
      safety of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma. The
      primary objective is to assess ORR of SHR-1210 in patients with relapsed or refractory
      classic Hodgkin's lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically confirmed classic Hodgkin's lymphoma;

          2. 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;

          3. Subjects enrolled have measurable lesion (s) according to Lugano 2014 criteria;

          4. ECOG performance status of 0 or 1;

          5. Life expectancy ≥ 12 weeks;

          6. Adequate laboratory parameters during the screening period as evidenced by the
             following:

               1. Absolute neutrophil count ≥ 1.0 × 109/L;

               2. Platelets ≥ 75 × 109/L;

               3. Hemoglobin ≥ 8.0 g/dL;

               4. Total bilirubin (TBIL) < 1.5 × upper limit of normal (ULN), ALT and AST ≤
                  2.5×ULN;

               5. Serum Creatinine ≤1.25×ULN or Creatinine clearance≥45 mL/min;

               6. Coagulation function index: INR ≤1.5×ULN，APTT≤1.5×ULN;

          7. Women of childbearing potential (WOCBP) must be willing and able to employ a highly
             effective method of birth control/contraception to prevent pregnancy while on
             treatment and for at least 60 days after receiving the last dose of study treatment.
             Women of childbearing potential with pregnancy test negative within 7 days before
             entering the group; male subjects with WOCBP partner should receive Surgical
             sterilization or consent to employ a highly effective method of birth
             control/contraception to prevent pregnancy while on treatment and for at least 120
             days after receiving the last dose of study treatment;

          8. Able to understand and sign an informed consent form (ICF).

        Exclusion Criteria:

          1. Known nodular lymphoma predominant Hodgkin lymphoma or Grey zone lymphoma.

          2. Known central nervous system lymphoma.

          3. History and complication:

        (1) Active, known or suspected autoimmune disease. Subjects who were in a stable state
        without systemic immunosuppressive therapy were admitted; (2) Concurrent medical condition
        requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic
        corticosteroids > 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.

        4. laboratory test:

        (1) known HIV positive or known AIDS; (2) Untreated active hepatitis; co-infection with
        hepatitis B and hepatitis C.

        5. 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.