A Phase I/II Clinical Study to Evaluate the Efficacy and Safety of GW5282 in Combination With Golidocitinib in the Treatment of T-Cell Lymphoma
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.
• Signed informed consent;
• Adult ≥ 18 years of age;
• ECOG performance status score ≤ 2;
• Life expectancy of not less than 12 weeks;
• Histopathologically confirmed diagnosis of PTCL;
• Presence of measurable disease;
• Adequate bone marrow function and vital organ function reserve;
• Ability to comply with study requirements and to complete study-related procedures;
• Adequate contraception during participation in the trial.