JAK1 Inhibitor Golidocitnib for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas

Exploratory Clinical Study of JAK1 Inhibitor Golidocitnib in the Treatment of Relapsed/Refractory Indolent T/NK-Cell Lymphomas：An Open, Prospective, Exploratory Clinical Trial

Indolent T/NK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from T/NK cells, characterized by slow growth and proliferation, but currently remain incurable. For indolent T/NK-cell lymphomas that are unresponsive to first-line treatment, there are few treatment options available and the prognosis is poor. This study is an open-label, prospective clinical trial aimed at evaluating the feasibility, efficacy, and safety of PI3K inhibitors in the treatment of relapsed/refractory indolent T/NK-cell lymphomas. Patients will be treated with Golidocitnib, with an expected overall response rate of 60% for JAK1 inhibitor Golidocitnib treatment.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma, T-Cell; Mycosis Fungoides; Cutaneous T Cell Lymphoma; Large Granular Lymphocytic Leukemia; Large Granular Lymphocyte Leukemia; Cutaneous T Cell Lymphoma (CTCL); T-LGL Leukemia; NK-LGL Leukemia; Indolent T-Cell Lymphoproliferative Disorder of the Gastrointestinal Tract; Primary Cutaneous Acral CD8-Positive T-Cell Lymphoma
• Intervention / Treatment: Drug: JAK1 Inhibitor

Detailed Description

Plan to enroll 48 patients with relapsed/refractory indolent T/NK-cell lymphomas; they will receive JAK1 inhibitor treatment (Golidocitnib150mg QD orally, with a 28-day cycle). Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shuhua Yi, Doctor; Phone Number: 86-22-23909106; Email: yishuhua@ihcams.ac.cn
• Study Contact Backup: Name: Lugui Qiu, Doctor; Phone Number: 86-22-23909172; Email: qiulg@ihcams.ac.cn

Study Locations

• China
  • Tianjin, China, 300020
    • Not yet recruiting
    • Institute of Hematology & Blood Diseases Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300020
      • Recruiting
      • Institute of Hematology & Blood Diseases Hospital, China
      • Principal Investigator: Shuhua Yi, Doctor
      • Contact: Shuhua Yi, Doctor; Phone Number: 86-22-23909106; Email: yishuhua@ihcams.ac.cn
      • Contact: Lugui Qiu, Doctor; Phone Number: 86-22-23909172; Email: qiulg@ihcams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years, with no restrictions on gender;
2. Histologically confirmed relapsed/refractory (R/R) indolent T/NK-cell; lymphoma that has failed at least one systemic therapy or is intolerant to such treatment and/or currently has no effective standard treatment options;
3. The patient meets the criteria for appropriate therapeutic indications;
4. ECOG performance status of 0-2;
5. Adequate organ function, defined as: Total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; Blood urea nitrogen (BUN)/Urea and creatinine (Cr) ≤ 1.5 × ULN; Left ventricular ejection fraction (LVEF) ≥ 50%; Fridericia-corrected QT interval (QTcF): < 450 ms for males, < 470 ms for females;
6. An expected survival time of at least 3 months;
7. Male and female subjects of childbearing potential must agree to use effective contraception throughout the study period and for 6 months after the last dose of the investigational drug;
8. A washout period of ≥ 4 weeks since receiving any prior antitumor therapies (including radiotherapy, chemotherapy, hormone therapy, surgery, or molecular targeted therapy) before participating in this study;
9. The subject has not participated in any other clinical trial within 1 month prior to enrollment;
10. The subject agrees to and signs the informed consent form.

Exclusion Criteria:

1. Subjects who have previously used any JAK inhibitors;
2. Subjects with clinical conditions such as dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and/or absorption of the study drug;
3. Subjects with active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);
4. Subjects with HBV or HCV infections, defined as HBsAg and/or HBcAb positivity and HBV DNA copy number ≥ the upper limit of normal (ULN), or acute or chronic active hepatitis C (HCV antibody-positive);
5. Subjects with a history of immunodeficiency, including those who are HIV-positive, or those with other acquired or congenital immunodeficiency diseases, a history of organ transplantation, or a history of allogeneic bone marrow or hematopoietic stem cell transplantation;
6. Subjects who have undergone autologous hematopoietic stem cell transplantation within 90 days prior to the first dose of study treatment;
7. Subjects with severe or uncontrolled cardiovascular diseases;
8. Subjects with severe concomitant diseases that pose a significant risk to patient safety or, in the investigator's judgment, may interfere with the completion of the study (e.g., uncontrolled hypertension, diabetes, or thyroid disorders);
9. Pregnant or breastfeeding female subjects, or baseline positive pregnancy test results in women of childbearing potential;
10. Subjects with a history of other malignancies diagnosed or treated within the past 5 years;
11. Any other conditions that, in the investigator's opinion, render the subject unsuitable for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JAK1 inhibitor; Golidocitnib 150mg QD orally	Drug: JAK1 Inhibitor; Golidocitnib 150mg QD orally, with a 28-day cycle. Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate	complete remission rate + partial remission rate	up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete remession rate	Hematological PR was defined as an improvement in blood counts ANC > 0.5 × 109/L; HGB increased by >1 g/dL; PLT > 50 × 109/L	up to 5 years
Overall survival	The time from the start of treatment to the patient's death from any cause	up to 5 years
Duration of remission	the time from response to progression/death (P/D)	up to 5 years
Time to response	from the start of treatment to the first observed partial remission	up to 5 years
Progression-free survival	the time from treatment initiation until disease progression or death	up to 5 years
Disease control rate	the proportion of patients whose tumors have not progressed after treatment over a specific period of time. Specifically, DCR includes the percentage of patients who achieve complete response (CR), partial response (PR), and stable disease (SD).	up to 5 years
The safety of JAK1 inhibitor	Incidence of adverse events, serious adverse events and significant adverse event	up to 5 years

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital, China
• Collaborators: The First Affiliated Hospital of Nanchang University; Henan Cancer Hospital; Tongji Hospital; The First Hospital of Jilin University; Tianjin First Central Hospital; Second Xiangya Hospital of Central South University; The First Affiliated Hospital of Air Force Medicial University

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2024
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2028

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: JAK1 inhibitor; Indolent T/NK-cell lymphomas
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Leukemia, Lymphoid; Leukemia; Leukemia, T-Cell; Hemic and Lymphatic Diseases; Lymphoma, T-Cell; Lymphoma, T-Cell, Cutaneous; Leukemia, Large Granular Lymphocytic; Mycosis Fungoides
• Other Study ID Numbers: IIT2024084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No