Golidocitinib and Chidamide for Cutaneous T-Cell Lymphoma Phase I/II Trial

NCT07754890 | Recruiting Phase 1

• 1 other identifier: K8777
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-center phase I/II study, with the purpose of evaluating the efficiency of golidocitinib combined with chidamide in patients with systemically-treated cutaneous T-cell lymphoma. The primary endpoint of the phase I study was to determine the recommended phase II dose (RP2D), while the primary endpoint of the phase II study was the objective response rate (ORR). Secondary endpoints included the complete response (CR) rate, progression-free survival (PFS), duration of response (DOR), overall survival (OS), and safety profile.

Conditions

Cutaneous T-cell Lymphoma (CTCL)

Keywords

cutaneous T-cell lymphoma

Outcome Measures

Primary Outcomes (2)

• Recommended Phase II Dose (RP2D)

  The RP2D is determined based on the occurrence of dose-limiting toxicities (DLTs) during the first cycle (28 days) of treatment. It is defined as the highest dose level at which fewer than 33% of participants experience a DLT.

  From enrollment to the end of treatment at 4 weeks

• Objective Response Rate (ORR)

  ORR is defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR).

  From enrollment to the end of 2-year follow-up phase or disease progression or death due to any cause

Secondary Outcomes (3)

• Complete Response (CR) Rate

  From enrollment to the end of 2-year follow-up phase or disease progression or death due to any cause

• Progression-Free Survival (PFS)

  From enrollment to the end of 2-year follow-up phase or disease progression or death due to any cause

• Overall Survival (OS)

  From enrollment to the end of 2-year follow-up phase or death from any cause

Study Arms (1)

Golidocitinib and Chidamide

EXPERIMENTAL

The phase I dose levels are golidocitinib 150 mg every other day and 150 mg once daily. In the phase II segment, golidocitinib will be administered at the RP2D established in the phase I study. Chidamide is administered at a fixed dose of 20 mg twice weekly.

Drug: golidocitinib; Drug: Chidamide

Interventions

golidocitinib DRUG

The phase I dose levels are golidocitinib 150 mg every other day and 150 mg once daily. In the phase II segment, golidocitinib will be administered at the RP2D established in the phase I study.

Golidocitinib and Chidamide

Chidamide DRUG

Chidamide is administered at a fixed dose of 20 mg twice weekly.

Golidocitinib and Chidamide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Wei Zhang

CONTACT

13681473557; vv1223@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: August 10, 2026
• Study Start: August 26, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

CN (1)