Golidocitinib and Chidamide for Cutaneous T-Cell Lymphoma

of golidocitinib in combination with chidamide and to determine the recommended phase II dose (RP2D). The study follows a standard "3+3" design. The starting dose of golidocitinib is 150 mg every other day, with pre-specified dose levels including 150 mg every other day and 150 mg once daily. Chidamide is administered at a fixed dose of 20 mg twice weekly. In the phase II segment (dose expansion phase), all participants will receive the combination therapy of golidocitinib and chidamide. Golidocitinib will be administered at the RP2D established in the phase I study, while chidamide will continue at the fixed dose of 20 mg twice weekly. Each treatment cycle is defined as 4 weeks. Tumor response will be assessed every 3 treatment cycles, and safety evaluations will be performed every cycle.

Inclusion criteria

• Histopathologically confirmed cutaneous T-cell lymphoma.
• Patients with measurable disease, with or without extracutaneous lesions, and clinical stage IB-IVB.
• Disease that has not responded to or has relapsed after at least one prior systemic therapy (including, but not limited to, total skin electron beam therapy, bexarotene, retinoids, interferon, extracorporeal photopheresis, methotrexate, or chidamide).
• An ECOG performance status of 0 to 2.
• Adequate bone marrow function: Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L, Platelet count (PLT) ≥80×10⁹/L, Hemoglobin (HGB) ≥90 g/L.
• Adequate organ function: Cardiac function Class 1-2 (NYHA), Left Ventricular Ejection Fraction (LVEF) ≥50%, Alanine Aminotransferase (ALT) < 2.5 × Upper Limit of Normal (ULN), Total Bilirubin (TBil) < 1.5 × ULN, Oxygen Saturation (SpO₂) > 93% on Room Air, estimated Glomerular Filtration Rate (eGFR) based on serum creatinine (sCr) > 60 mL/min/1.73m².

Exclusion criteria

• Acute myocardial infarction, unstable angina, congestive heart failure, symptomatic arrhythmia within the past 6 months, or significant QT interval prolongation (corrected QT interval >450 ms in males or >470 ms in females).
• Uncontrolled active infection.
• Active tuberculosis infection.
• Active Hepatitis B (HBV DNA > 1×10³ copies/mL) or Hepatitis C (HCV RNA > 1×10³ copies/mL) infection.
• Pregnancy or lactation.
• Any other condition deemed by the investigator as unsuitable for participation in this study.