A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)

Inclusion Criteria

• Subject must have a histologically confirmed NKTL at study site.
• Subject must have relapsed or refractory NKTL after prior asparaginase-based chemotherapy or chemo radiotherapy.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
• Subject must have at least one evaluable or measurable lesion per Lugano 2014 classification.
• Subject must have adequate organ function and bone marrow function without severe hematopoietic disorder, or heart, lung, liver or kidney dysfunction or immune deficiency.
• Subject must provide stained tumor tissue sections and corresponding pathological report or unstained tumor tissue sections (or tissue block) for central pathology review.
• Subject with prior anti-cancer treatment can only be enrolled when the toxicity of prior anti-cancer treatment has recovered to baseline or ≤ Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03.

Exclusion Criteria

• Invasive natural killer leukemia.
• Concomitant with hemophagocytic syndrome.
• Primary site in central nervous system (CNS) or CNS involvement.
• Subjects currently participating in other clinical studies or use of any investigational drug within 4 weeks prior to the first dose of CS1001.
• Subjects who received systemic corticosteroid or any other immunosuppressive therapy within 14 days prior to the first dose of CS1001.
• Subjects who had prior chemotherapy, immune therapy, biological therapy as systemic treatment for cancer, within 28 days prior to the first dose of CS1001.
• Receipt of traditional medicinal herbal preparations with anti-tumor indications with 7 days prior to the first dose of CS1001.
• Known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome.
• Subjects with active hepatitis B or C infection.
• Subjects with active tuberculosis infection.
• Subjects who received prior therapy with anti-PD-1, anti-PD-L1 or anti-CTLA-4 monoclonal antibody.
• Female subjects who are pregnant or breast-feeding. For more information regarding trial participation, please contact at cstonera@cstonepharma.com