Clinical Study of XNW5004 Combined With CHOP/CHOEP in the Treatment of Untreated Peripheral T-Cell Lymphoma

Inclusion criteria

• 1. Age: 18 - 75 years old (inclusive of 18 and 75 years old); Gender: No restrictions; 2. Pathologically confirmed peripheral T-cell lymphoma (refer to Appendix 3); 3. Has not received systematic treatment for PTCL； 4. At least one measurable lesion for assessment: nodal lesions with a longest diameter > 1.5 cm; extranodal lesions with a longest diameter > 1.0 cm; 5. Expected survival at least 12 weeks； 6. ECOG physical score of 0-1 (refer to Appendix 4)； 7. Essential organ function reserves meet the following requirements：

• Hematopoietic function： a) White blood cell count ≥ 3.5 × 10^9/L (within 1 week before the blood routine examination in the screening period， no use of G-CSF， no use of long-acting white blood cell growth factors within 2 weeks)； b) Platelet count ≥ 75 × 10^9/L (within 1 week before the blood routine examination in the screening period， no blood transfusion of platelets， no use of TPO receptor agonists)； c) Hemoglobin ≥ 80 g/L (within 1 week before the blood routine examination in the screening period， no blood transfusion of red blood cells， no use of EPO)；
• Liver function： Serum total bilirubin ≤ 1.5 × ULN (Gilbert's syndrome ≤ 3 ULN)， and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN； for liver-infiltrated subjects， ALT/AST ≤ 5 × ULN； for liver and/or bone-infiltrated subjects， alkaline phosphatase ≤ 5 × ULN；
• Kidney function： Serum creatinine ≤ 1.5 × ULN or estimated creatinine clearance rate based on the Cockcroft-Gault formula ≥ 60 mL/min (Cockcroft-Gault formula， refer to Appendix 4)；
• Left ventricular ejection fraction (LVEF) ≥ 50%；
• International normalized ratio (INR) ≤ 1.5 × ULN， or plasma prothrombin time (PT) and partial thromboplastin time (APTT) ≤ 1.5 × ULN.

• For pregnant women of childbearing age， before entering this study， the serum pregnancy test must be negative and they must agree to be completely protected from pregnancy from the start of the study until at least 6 months after the last administration of the investigational drug； For infertile female subjects， they should have experienced natural menopause for at least 12 months， and undergo female hormone testing， and be judged by a specialist as having no reproductive function before being eligible for enrollment； or the serum pregnancy test must have been negative at least 6 weeks before the screening period； For male subjects， they must agree to take adequate contraceptive measures from the start of the study until at least 6 months after the last administration of the investigational drug， and it is prohibited to donate sperm.

• Before starting the specific research procedures， a signed and dated written informed consent form must be provided， and they must be able to comply with clinical visits and research-related procedures.

Exclusion criteria

• 1. Has received any anti-tumor treatment before, including but not limited to: chemotherapy, immunotherapy, radiotherapy, targeted therapy, anti-tumor traditional Chinese medicine, anti-tumor experimental drugs; 2. Subjects who are known to be allergic to the test drug or its active ingredients, excipients; 3. Subjects who have undergone major surgery within 4 weeks before the first use of the test drug or who plan to undergo major surgery during this study (except for procedures such as puncture or lymph node biopsy); 4. Subjects who have previously or plan to receive allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 5. Subjects who received steroid hormones for anti-tumor purposes within 7 days before the first use of the test drug (daily dose > 20 mg of prednisone or equivalent dose of other glucocorticoids); or who need to use steroid hormones (daily dose > 10 mg of prednisone or equivalent dose of other glucocorticoids) or other immunosuppressive drugs for systemic treatment before the first use of the test drug within 14 days; provided that there is no active autoimmune disease, inhalation or topical use of glucocorticoids and adrenal replacement therapy with a daily dose ≤ 10 mg of prednisone or equivalent dose of other glucocorticoids is allowed; 6. Subjects who took known moderate or strong CYP3A4 inhibitors/inducers within 14 days before the first administration (see Appendix 5); 7. Subjects who received live virus vaccines (including attenuated live vaccines) within 28 days before administration. Live-inactivated vaccines are allowed; 8. Subjects with a history of substance abuse or drug addiction; 9. Subjects who have had other malignant tumors within 3 years before enrollment, and do not meet the criteria for clinical cure. The following situations are excluded: skin basal cell carcinoma or squamous cell carcinoma that can be treated locally and has been cured, superficial bladder cancer, cervical carcinoma in situ, breast intraductal carcinoma and thyroid papillary carcinoma; 10. Mycosis fungoides, Sezary syndrome and primary cutaneous T-cell lymphoma; 11. Central nervous system invasion; 12. Testicular or breast invasion; 13. Has had hemophagocytic syndrome in the past or currently; 14. Has had immune thrombocytopenia, autoimmune hemolytic anemia, aplastic anemia or other primary or secondary hematological diseases that may affect bone marrow function, except for primary malignant tumors; 15. past or current acute myeloid leukemia (AML); 16. Past or current T-cell lymphoblastic lymphoma (T-LBL) or T-cell lymphoblastic leukemia (T-ALL); 17. Any history of myeloid malignancies, including myelodysplastic syndrome (MDS), or abnormal test indicators related to MDS or myeloproliferative neoplasms (MPN); 18. Has or has been accompanied by central nervous system lesions, including but not limited to: epilepsy, paralysis, stroke, severe brain injury, Alzheimer's disease, Parkinson's disease, cerebellar disease, brain organic syndrome, psychosis, etc.; 19. Cardiac function impairment or severe cardiac disease, including any of the following:

• Acute myocardial infarction within 12 months before the first administration;
• Unstable angina pectoris;
• Congestive heart failure (New York Heart Association cardiac function classification of grade III or IV, see Appendix 6);
• Uncorrected severe arrhythmia, hypertension ≥ 150/100 mmHg;
• QTc interval prolongation (defined as > 450 ms for males and > 470 ms for females) (Fredericia's formula, see Appendix 7);
• Past history of other major cardiovascular diseases (such as valve replacement surgery, coronary artery bypass surgery, etc.); 20. The tumor invades surrounding vital organs and blood vessels (such as the heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc.) and there is a risk of bleeding or the risk of developing esophageal-tracheal fistula or esophageal-pulmonary fistula; 21. Subjects with clinical symptoms and poor control after repeated treatment of pleural and pericardial effusion, or pericardial effusion; 22. Those with active systemic severe infection: at least 2 weeks of washout period is required after the completion of antifungal treatment (whether by intravenous administration or oral administration), at least 1 week of washout period is required after the completion of other intravenous anti-infection treatment, and other oral anti-infection treatment should be stopped before the first administration of the study; 23. Those with active tuberculosis; 24. HIV positive, syphilis (Anti-TP) positive (if the non-specific antibody test result of syphilis is negative and the syphilis is judged to be cured by the investigator, then they will not be excluded); 25. HBsAg positive and HBV-DNA copy number higher than the normal lower limit of the detection value, or HBcAb positive and HBV-DNA copy number higher than the normal lower limit of the detection value; HCV antibody positive and HCV-RNA copy number higher than the normal lower limit of the detection value; 26. Subjects who cannot swallow, or those with active gastrointestinal inflammation, chronic diarrhea, known diverticulosis, or those with a history of diseases affecting drug absorption such as gastric resection or gastric banding. However, gastroesophageal reflux treated with proton pump inhibitors is allowed (if there is no possibility of drug interaction); 27. Known subjects with bleeding disorders such as von Willebrand disease or hemophilia, etc.; 28. Women in pregnancy or lactation; 29. Those who cannot complete this study for other reasons or those considered not suitable for inclusion by the investigator.