Assessing Treatment of T-Cell Lymphoma With GW5282 in Combination With Golidocitinib (BEI-DOU3)

This is a phase 1/2 open-label study to evaluate GW5282 in combination with golidocitinib (G2 regimen) for the treatment of T-cell lymphoma. In the first phase of the study, the maximum tolerated dose will be determined through dose escalation; in the second phase, the potential therapeutic advantages of the novel combination therapy over the conventional CHOP regimen will be preliminarily assessed through a randomized controlled design.

Inclusion Criteria: 1. Signed informed consent; 2. Adult ≥ 18 years of age; 3. ECOG performance status score ≤ 2; 4. Life expectancy of not less than 12 weeks; 5. Histopathologically confirmed diagnosis of PTCL; 6. Presence of measurable disease; 7. Adequate bone marrow function and vital organ function reserve; 8. Ability to comply with study requirements and to complete study-related procedures; 9. Adequate contraception during participation in the trial. Exclusion Criteria: 1. Presence of unresolved drug-related adverse events greater than Grade 1; 2. Lymphoma involving the central nervous system; 3. Failure to complete the required washout period for other anti-tumor therapies; 4. Corticosteroid use that does not meet protocol requirements; 5. Major surgery/trauma within a short period, or planned major surgery within a short period; 6. Vaccination with a live vaccine within a short period; 7. Inability to discontinue prohibited medications; 8. Requirement for immunosuppressive agents or biologics due to an underlying disease; 9. Presence of active infection; 10. Significant cardiovascular disease; 11. Presence of gastrointestinal disease that might affect drug intake or absorption; 12. History of other malignancies; 13. Known allergy to the study drug; 14. Other severe or uncontrolled systemic diseases; 15. Personnel with a conflict of interest (e.g., site staff, sponsor employees); 16. Pregnant or breastfeeding women; 17. Inability to comply with protocol requirements.