Sintilimab (IBI308) in Combination With Chidamide and Azacitidine in Refractory or Relapsed PTCL

Inclusion Criteria:

* Histopathologically confirmed PTCL;
* Disease status defined as relapsed or refractory after \>=1 prior treatment lines;
* Prior use of HDACi or PD-1/PD-L1 antibodies or demethylation drugs is allowed;
* At least one measurable disease (defined as ≥ 1.5 cm in length-diameter, or 1.1\~1.5 cm in length-diameter and \>1.0 cm in short-diameter ) ；
* ECOG PS 0\~2；
* Provide written informed consent for the trial；
* 18 ≤ age ≤ 80；
* Life expectancy ≥12 weeks;
* Adequate organ and bone marrow function, laboratory tests should be received within 7 days prior to the use of the research drug and meet the eligibility requirements;
* Subjects of reproductive potential must be willing to use adequate contraception during the course of the study and through 120 days after the last dose of study medication.

Exclusion Criteria:

* Known central nervous system lymphoma or cutaneous T-cell lymphoma;
* Received any immunesuppressive drugs within 4 weeks of the first dose of study medicationy, not including topical corticosteroids or systemic corticosteroids in physiological doses (≤10 mg/day prednisone or equivalent dose of other steroid);
* Patients with active autoimmune diseases requiring systematic treatment in the past two years;
* Received or plan to receive any attenuated vaccines within 4 weeks of the first dose of study medication;
* Received the last anti-tumor therapy within 4 weeks of the first dose of study medication or have not recovered (recovery defined as baseline or ≤ grade 1) from adverse events due to anti-cancer agents;
* 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;
* Subjects with interstitial lung disease or lung disease that may interfere with the detection or treatment of suspected drug-related pulmonary toxicity;
* Other primary malignancy;
* Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation;
* Received autologous hemopoietic stem cell transplantation within 90 days of the first dose of study medication;
* Received major surgery or unhealed wound, ulcer or fracture within 4 weeks of the first dose of study medication;
* Active tuberculosis；
* Known primary immunodeficiency；
* Known allergy or hypersensitivity to any monoclonal antibodies or any components used in their preparation;
* Uncontrolled concomitant disease;
* Patients with active hepatitis. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA titer (no more than 50 IU/mL) and HCV RNA (no more than the lower limit of the detection method);
* History of gastrointestinal perforation and /or fistula within 6 months before enrollment;
* Hemophagocytic syndrome；
* Uncontrolled third space effusion, e.g. ascites or pleural effusion cannot be drained or controlled;
* Women who are pregnant or nursing；
* According to the researchers' judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions;
* Other researchers consider it unsuitable for patients to participate in this study.