Clinical Trial in Chinese Patients of Relapsed and Refractory Peripheral T Cell Lymphoma (GB226)

Inclusion Criteria:

1. Aged 18 years or older, male or female;
2. Understand study procedures and contents, and voluntarily sign the written informedconsent form;
3. Histologically confirmed relapsed or refractory PTCL patients who had receivedsystemic treatment at least once but had failed to or cannot tolerate the treatment,and/or who cannot be treated with effective standard therapies currently.
4. Available to provide tissue sample for pathological diagnosis;
5. ECOG score of 0-1;
6. Life expectancy≥3 months;
7. Computed tomography (ct) scans performed within 28 days of study administration shouldshow the presence of at least one of two vertical orientationsThe tumor lesions thatcould be measured were defined, with the longest diameter of intranode lesion > 1.5cmand the longest diameter of extranode lesion > 1.0cm (according to2014 luganostandard)
8. Systemic chemotherapy, systemic or local palliative radiotherapy, target therapy hasbeen completed for at least 4 weeks before enrollment.
9. Systemic corticosteroids (prednisone > 10 mg/day or equivalent dose) has beendiscontinued at least 2 weeks before enrollment;
10. Autologous hematopoietic stem cell transplantation (ASCT) has been completed at least 4 weeks before enrollment;
11. Before enrollment, major surgery requiring general anesthesia must have been completedat least 4 weeks; surgery requiring local anesthesia/epidural anesthesia must havebeen completed at least 2 weeks and the patients have recovered; skin biopsy requiringlocal anesthesia has been completed at least 1 hour.
12. The previous anti-tumor biotherapy (tumor vaccine aimed at controlling tumor, cytokineor growth factor) has been completed at least 4 weeks before enrollment.
13. For routine blood tests: hemoglobin ≥ 80 g/L, neutrophil ≥ 1.0 ×109/L, platelet ≥ 80×109/L;
14. Serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 50 mL/min (Cockcroft-Gaultformula);
15. Total bilirubin < 1.5 times the upper limit of normal (ULN), aspartateaminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times the upper limitof normal (ULN);
16. Thyroid function indicators: thyroid-stimulating hormone (TSH) and free thyroxine (FT3/FT4) are within the normal range;
17. The adverse reactions caused by the previous treatment should recover to grade 1 andbelow (except alopecia);
18. Females of child-bearing potential have negative serum pregnancy test; males orfemales agree to adopt medically confirmed contraceptive measures during the entirestudy and within 6 months after the end of this study.
19. Patients can receive follow-up visits as scheduled, well communicate with theinvestigators and complete the study as required by the study.

Exclusion Criteria:

1. Diagnosed as vascular immunoblastic t-cell lymphoma (AITL) or adult t-celllymphoma/leukemia(ATLL);
2. Defined central nervous system (CNS) infiltration of lymphoma, including brainparenchyma, meningeal infringement or spinal cord compression;
3. Previous history of organ transplantation or allogeneic hematopoietic stem celltransplantation;
4. Patients who have active, known or suspected autoimmune diseases;
5. Patients who were previously treated with anti PD-1 antibody, anti PD-L1 antibody,anti PD-L2 antibody or anti CTLA-4 antibody (or any other antibodies acting on T cellco-stimulation or checkpoint pathway);
6. Complicated with other serious internal diseases, including but not limited touncontrolled diabetes mellitus, active gastrointestinal ulcers, active hemorrhage,etc.;
7. Received treatment with other study drugs within 30 days before administration of thestudy drug or before 5 half-lives of other study drugs (whichever is shorter); or useof investigational medical device within 30 days;
8. Patients with active pulmonary tuberculosis; patients who previously had activepulmonary tuberculosis;
9. Any of the following is positive: hepatitis B surface antigen (HBsAg), hepatitis Cantibody (HCV-Ab), acquired immunodeficiency syndrome antibody (Anti-HIV) andanti-treponema pallidum antibody (TP-Ab);
10. Patients with complications requiring treatment with immunosuppressive drugs orsystemic or local corticosteroids at the immunosuppressive doses;
11. Received treatment with other study drugs within 30 days before administration of thestudy drug or before 5 half-lives of other study drugs (whichever is shorter); or useof investigational medical device within 30 days;
12. Patients receiving any anti-infection vaccine (e.g. influenza vaccine, varicellavaccine etc.) within 4 weeks before enrollment;
13. Patients with symptomatic pleural, peritoneal and pericardial effusion;
14. Patients with drug abuse history or alcohol addiction history;
15. Uncontrollable or symptomatic dropsy of serous cavity, e.g. ascites, pleural effusionor pericardial effusion;
16. Lactating women;
17. Patients who had been previously treated with any other investigational drugs orparticipated in another clinical study within 30 days before enrollment;
18. Patients who are allergic to recombinant humanized antibody or any of its excipients;
19. Known allergies to recombinant humanized monoclonal antibody or any of its excipientcomponents; A known history of severe allergic disease;
20. Patients who have insufficient communication, understanding and cooperation; orpatients who have poor compliance and cannot guarantee to strictly follow the studyprotocol;
21. Subjects who are considered unsuitable for participating in this study for variousreasons at the discretion of the investigator.