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Center","RECRUITING","Shanghai",{"type":49,"coordinates":157},[158,159],121.45806,31.22222,{"lat":159,"lon":158},[162],{"name":163,"role":37,"phone":11,"phoneExt":11,"email":11},"Tao",{"facility":165,"status":43,"city":166,"state":11,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Shanxi Provincial Cancer Hospital","Taiyuan",{"type":49,"coordinates":168},[169,170],112.56028,37.86944,{"lat":170,"lon":169},[173],{"name":174,"role":37,"phone":11,"phoneExt":11,"email":11},"Su",{"facility":176,"status":43,"city":83,"state":11,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":177,"geoPoint":179,"contacts":180},"Henan Cancer Hospital",{"type":49,"coordinates":178},[87,88],{"lat":88,"lon":87},[181],{"name":182,"role":37,"phone":11,"phoneExt":11,"email":11},"Zhou",{"type":184,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100631096","phase-1-assessing-treatment-of-t-cell-lymphoma-with-gw5282-in-combination-with-golidocitinib-bei-dou3-100631096",false,"NCT07496229","Assessing Treatment of T-Cell Lymphoma With GW5282 in Combination With Golidocitinib (BEI-DOU3)","A Phase I\u002FII Clinical Study to Evaluate the Efficacy and Safety of GW5282 in Combination With Golidocitinib in the Treatment of T-Cell Lymphoma","Inclusion Criteria:\n\n1. Signed informed consent;\n2. Adult ≥ 18 years of age;\n3. ECOG performance status score ≤ 2;\n4. Life expectancy of not less than 12 weeks;\n5. Histopathologically confirmed diagnosis of PTCL;\n6. Presence of measurable disease;\n7. Adequate bone marrow function and vital organ function reserve;\n8. Ability to comply with study requirements and to complete study-related procedures;\n9. Adequate contraception during participation in the trial.\n\nExclusion Criteria:\n\n1. Presence of unresolved drug-related adverse events greater than Grade 1;\n2. Lymphoma involving the central nervous system;\n3. Failure to complete the required washout period for other anti-tumor therapies;\n4. Corticosteroid use that does not meet protocol requirements;\n5. Major surgery\u002Ftrauma within a short period, or planned major surgery within a short period;\n6. Vaccination with a live vaccine within a short period;\n7. Inability to discontinue prohibited medications;\n8. Requirement for immunosuppressive agents or biologics due to an underlying disease;\n9. Presence of active infection;\n10. Significant cardiovascular disease;\n11. Presence of gastrointestinal disease that might affect drug intake or absorption;\n12. History of other malignancies;\n13. Known allergy to the study drug;\n14. Other severe or uncontrolled systemic diseases;\n15. Personnel with a conflict of interest (e.g., site staff, sponsor employees);\n16. Pregnant or breastfeeding women;\n17. Inability to comply with protocol requirements.","ALL","18 Years",{"count":195,"type":196},165,"ESTIMATED","INTERVENTIONAL",[199,200],"PHASE1","PHASE2","This is a phase 1\u002F2 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.",[203],"T-cell Lymphomas","2026-04-16",{"date":206,"type":207},"2026-04-17","ACTUAL",{"date":209,"type":207},"2026-04-15",{"date":211,"type":196},"2029-12",{"name":5,"class":6},12]